Whitney Labs = c/o Colonial Management Group, LP, Warning Letter

From: Subject: Whitney Labs c/o Colonial Management Group, LP, Warning Letter Date: Wed, 10 Dec 2008 14:44:23 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C95AD5.CAAC4070" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C95AD5.CAAC4070 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s7045c.htm Whitney Labs = c/o Colonial Management Group, LP, Warning Letter

FDA Home = Page | Search FDA Site | FDA A-Z Index | Contact FDA

3D"horizontal


Department of Health and Human Services	Public Health Service Food and Drug = Administration
	555 Winderley Pl., Ste. 200 Maitland, Fl 32751=20

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-08-27

September 2, 2008

Whitney Labs
c/o Colonial Management Group, LP
T. Mark = Gallagher,=20 President/CEO
14050 Town Loop Boulevard, Suite 204
Orlando, = Florida=20 32837

Dear Mr. Gallagher:

On March 12, 13, 14, and 17, 2008, the United States Food and Drug=20 Administration (FDA) conducted an inspection of Whitney Labs, your = prescription=20 drug products repackaging and relabeling facility located at 1095 North = US=20 Highway 1, Suites #1-4, Ormond Beach, Florida 32174-1921. The inspection = revealed numerous significant deviations from the current good = manufacturing=20 practice (CGMP), Title 21 Code of Federal Regulations Parts 210 and 211 = (21 CFR=20 Parts 210 and 211), in the repackaging and relabeling of drug products,=20 including, but not limited to, the Schedule II controlled substance = Methadone=20 HCI in solid and liquid oral dosage forms. These deviations cause your = finished=20 drug products to be adulterated within the meaning of Section = 501(a)(2)(B) of=20 the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. =A7 = 351(a)(2)(B)].=20 Furthermore, the inspection revealed that your firm was responsible for=20 manufacturing [(b)(4)] unit-doses of Methadone HCI = 260mg/26mL=20 in liquid oral dosage form that were mislabeled as 20mg/2mL Methadone = HCI. These=20 drug products are misbranded within the meaning of Section 502(b)(2) of = the Act=20 [21 U.S.C. 352(b)(2)] in that the labels for these packaged drug = products did=20 not bear an accurate statement of the quantity of the contents in terms = of=20 weight, measure, or numerical count.

We acknowledge receipt of your April 14, 2008 written response to the = FDA=20 483, Inspectional Observations. We note that some corrections appear to = have=20 been implemented and that you have promised that others will soon be=20 implemented. However, your response does not adequately address some of = the=20 deficiencies, as further discussed below. Specific areas of concern = include, but=20 are not limited to:

1. Failure to have a quality control unit [21 CFR =A7 = 211.22].=20 Specifically, you have neither designated in writing nor in practice a = quality=20 control unit with the following functions: the responsibility and = authority to=20 approve or reject all components, drug product containers, closures,=20 in-process materials, packaging material, labeling, and drug products; = the=20 authority to review production records to assure that no errors have = occurred=20 or, if errors have occurred, that they have been fully investigated; = and the=20 responsibility for approving or rejecting all procedures or = specifications=20 impacting on the identity, strength, quality, and purity of drug = products. We=20 acknowledge your correspondence of April 14, 2008, in response to the = FDA 483,=20 which promises the establishment of a quality control unit and revised = procedures describing its functions by July 1, 2008. However, your = firm has=20 not provided any documentation of these corrections. (FDA 483 = Observation=20 1)

2. Failure to establish written procedures for production and = process=20 control designed to assure that the drug products have the identity, = strength,=20 quality, and purity they purport or are represented to possess [21 = CFR =A7=20 211.100(a)]. For example, your firm's automated packaging line = processes=20 and their respective software systems have not been validated. Your = response=20 to the FDA 483 response is inadequate because it fails to include any = detail=20 on the specific steps your firm intends to take to verify the proper=20 functioning of the referenced equipment. (FDA 483 Observation = 2)

3. Failure to follow written production and process control = procedures in=20 the execution of the various production and process control functions = and to=20 document them at the time of performance [21 CFR =A7 = 211.100(b)]. For=20 example, on February 11, 2008, your firm's production line employee(s) = involved in the manufacture of liquid oral Methadone HCI failed to = follow your=20 firm's procedures and document their actions at the time of = performance=20 regarding label changeovers between production runs and verification = of=20 processing equipment including settings prior to changing fill-sizes. = As a=20 result, [(b)(4)] unit doses of 260mg/mL liquid oral = Methadone=20 HCI were mislabeled as 20mg/2mL liquid oral Methadone HCI,=20 [(b)(4)] unit-doses of which were subsequently = distributed.=20 Your FDA 483 response states that retraining of employees has already = taken=20 place, but does not describe any other measures you may have taken to = ensure=20 adherence to written procedures in the future. (FDA 483 = Observation=20 3)

4. Failure to thoroughly investigate any unexplained discrepancies = or=20 failures of a batch or any of its components to meet any of its = specifications=20 [21 CFR =A7 211.192]. For example, the mislabeling of 300 = unit-doses of=20 260 mg/26 mL liquid oral Methadone HCI and reports of leaking = containers and=20 missing labels received by your firm were not investigated to = determine root=20 causes and no corrective or preventive action was implemented. Your = FDA 483=20 response is inadequate because it does not address the need to = investigate=20 unexplained discrepancies or failures of a drug product or component = to meet=20 specifications even when there is no complaint involved. (FDA 483=20 Observation 5)

5. Failure to establish written procedures describing in sufficient = detail=20 the receipt, identification, storage, handling, sampling, testing, = approval,=20 and rejection of components, containers, and closures [21 CFR =A7=20 211.80(a)]. For example, your firm has no procedures requiring = testing of=20 drug product components, containers or closures for solid and liquid = oral=20 dosage form Methadone HCI, 40cc unit-dose. The corrective action = described in=20 your FDA 483 response is inadequate because it does not state how your = firm=20 intends to address the specific inspectional observations concerning = drug=20 product components, containers and closures. (FDA 483 Observation = 4)=20

6. Failure to establish and follow written procedures describing = the=20 handling of all written and oral complaints regarding drug products = [21=20 CFR =A7 211.198(a)]. For example, your firm has not established = written=20 procedures describing the handling of complaints that include = provisions for:=20 1) review by a quality control unit of any complaint indicating a = possible=20 failure of a drug product to meet its specifications, 2) a = determination of=20 the need for an investigation of any such possible failure or = unexplained=20 discrepancy, and 3) review to determine if the complaints represent = serious=20 and unexpected adverse drug experiences which are required to be = reported to=20 FDA. Your FDA 483 response states that revised procedures will be in = place by=20 June 1, 2008, that will address the specific inspectional = observations.=20 However, you have not provided any additional follow up documentation = to=20 demonstrate that corrective actions have been implemented. (FDA = 483=20 Observation 5)

7. Failure to adequately train employees engaged in the = manufacture,=20 processing or holding of a drug product in CGMP or in the particular=20 operations performed by the employees [21 CFR =A7 211.25(a)]. = For=20 example, employees engaged in the production of 260mg/26mL liquid oral = Methadone HCI, lot #5464L, which was mislabeled as 20mg/2mL, did not = follow=20 your from's written procedures pertaining to product changeover on the = Auto=20 Labe labeling system or those requiring documentation of filler = settings. In=20 addition, according to employee training as maintained in the human = resource=20 files for employees engaged in the production of 260mg/26mL liquid = oral=20 Methadone HCI, lot #5464L, those employees received no GMP training, = conducted=20 on a continuing basis and with sufficient frequency, to ensure = familiarity=20 with applicable CGMP requirements. Whitney Labs also failed to comply = with=20 Section 1.4.1 of its training procedure to implement and document new = hire=20 training activities for employees engaged in the production of drug = products.=20 Your FDA 483 response states that retraining of employees on existing=20 procedures took place on May 15, 2008. In addition, the response = states that=20 training will be on a continuing basis; however, details are not = provided=20 regarding the frequency of the retraining. (FDA 483 Observation = 8)=20

8. Failure to establish a written testing program designed to = assess the=20 stability characteristics of your firm's repackaged solid and liquid = oral=20 dosage form Methadone HCI to determine appropriate storage conditions = and=20 expiration dates [21 CFR =A7 211.166(a)]. For example, your = firm's=20 procedure whereby an expiration date of one year past the date of = repackaging=20 is assigned to unit dose containers is not sufficient to provide = assurance=20 that the drug products will meet all applicable standards of identity, = strength quality and purity at time of use since it does not include = an=20 assessment of the expiration date of the bulk drug product or address = the=20 effect of multiple openings of the bulk drug product container prior = to=20 repackaging. Pursuant to 21 CFR =A7 211.137, expiration dates must be = supported=20 by appropriate stability testing described in a written program, which = your=20 firm has not established. The corrective action described in your FDA = 483=20 response is unsatisfactory because it does not address how your firm = intends=20 to assign expiration dates to repackaged unit dose drug products while = the=20 stability studies are being conducted. (FDA 483 Observation = 6)

9. Failure to retain reserve samples from representative lots or = batches of=20 drug products and to conduct visual examinations of such samples for = evidence=20 of deterioration on an annual basis [21 CFR =A7 211.170(b)].=20 Specifically, your firm does not retain reserve samples. The = corrective action=20 described in FDA 483 response appears to be satisfactory. However, = your firm=20 has provided no documentation of this correction. (FDA 483 = Observation=20 7)

10. Failure to establish written procedures for conducting annual = reviews=20 to evaluate the quality standards of each drug product to determine = the need=20 for changes in drug manufacturing or control procedures [21 CFR = =A7=20 211.180(e)]. Specifically, no annual product reviews are = conducted and=20 your firm does not maintain written procedures for conducting such = reviews.=20 Your FDA 483 response does not address conducting annual product = reviews.=20 (FDA 483 Observation 7)

In addition, we have determined that the aforementioned=20 [(b)(4)] unit-doses of 260mg/26mL Methadone HCI in = liquid oral=20 dosage form that your firm mislabeled as 20mg/2mL Methadone HCI, Lot = #5364L, are=20 misbranded within the meaning of Section 502(b)(2) of the Act [21 U.S.C. = 352=20 (b)(2)] in that the labels for these packaged drug products do not bear = an=20 accurate statement of the quantity of the contents in terms of weight, = measure,=20 or numerical count.

This letter is not intended to be an all-inclusive list of the = violations at=20 your facility. It is your responsibility to ensure compliance with = applicable=20 laws and regulations administered by FDA.

As we noted above, we have received your firm's written response to = the FDA=20 483 and we appreciate the statement by your Operations Manager, Ms. = Hunter, that=20 your firm is "prepared to take all necessary steps to ensure compliance = in all=20 areas." We acknowledge that your firm's Corrective Action Plan, which = provides=20 an outline of your firm's proposed corrective actions for each of the=20 objectionable observations listed on the FDA 483, includes an expected = date of=20 completion for all corrective actions of September 1, 2008. We also = acknowledge=20 that, during the inspection, Ms. Hunter reported to our investigator = that, as of=20 February 15, 2008, your firm had identified the locations of all=20 [(b)(4)] unit-doses of the misbranded Methadone HCI,=20 [(b)(4)] unit-doses of which were distributed by your = firm to=20 narcotic detoxification treatment clinics located in New Hampshire, = North=20 Carolina, Alabama, and Florida. However, we are concerned that, as of = the time=20 of the inspection, only one (1) of the six (6) treatment centers = receiving=20 affected drug products had returned the misbranded Methadone HCI for=20 destruction.

Your firm's April 14, 2008, response is not adequate, in that your = proposed=20 corrective actions to the CGMP violations do not, for the reasons listed = above,=20 alleviate our concerns regarding the identity, strength, quality and = purity of=20 drug products repackaged and relabeled by your firm.

Moreover, FDA has evaluated the degree of the health hazard = associated with=20 use of these misbranded unit-doses of Methadone HCI by the general adult = population and has determined that overdose with methadone is highly = likely to=20 cause fatal respiratory depression and cardiac arrhythmia. Due to the=20 life-threatening health risk of methadone overdose to patients for whom = your=20 firm's misbranded Methadone HCI, Lot #5364L, was intended, your firm's = response=20 is also inadequate in that no documentation regarding the final = disposition of=20 the entire lot of affected drug product was provided, without which we = cannot=20 evaluate and determine the effectiveness of your corrective actions. =

Please notify this office in writing within fifteen (15) working days = from=20 the date you receive this letter of the specific steps you have taken to = correct=20 the noted violations. Include documentation of the corrective actions = you have=20 taken, such as: any new or revised procedures or policies, including = validation=20 protocols; training records; and copies of records documenting the final = disposition of all unit-doses of Methadone HCI, Lot #5364L. Regarding = your=20 planned corrections that will occur over time, please include any = appropriate=20 revisions to the timetable for implementation of corrective actions = (i.e., the=20 Corrective Action, Plan) that was previously submitted with your = response dated=20 April 14, 2008. If corrective actions cannot be completed within 15 = working=20 days, state the reason(s) for the delay and the time within which the=20 corrections will be completed.

You should take prompt action to correct the violations addressed in = this=20 letter. Failure to promptly correct these violations may result in = regulatory=20 action being initiated by the Food and Drug Administration without = further=20 notice. These actions include, but are not limited to, seizure and = injunction.=20 Also, federal agencies are advised of the issuance of all Warning = Letters about=20 drugs so that they may take this information into account when = considering the=20 award of contracts.

Please send your response to the U.S. Food and Drug Administration,=20 Attention: Matthew B. Thomaston, Compliance Officer, 555 Winderley = Place, Suite=20 200, Maitland, FL 32751. If you have questions regarding any issue in = this=20 letter, please contact Mr. Thomaston at (407) 475-4728.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District

3D"horizontal

FDA/Freedom=20 of Information

------=_NextPart_000_0000_01C95AD5.CAAC4070 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/foi/graphics/mastheadart/images/fda_mast_01.gif R0lGODlhZABEALMAAJmZzDMzZszM/2ZmmTMzmf////8AAMzMzAAAZgAAAAAAAAAAAAAAAAAAAAAA AAAAACH5BAAAAAAALAAAAABkAEQAAAT/0MhJq7046827/2AojmRpnmiqrmzrvnAsz3Rt33h+I3zv /8CgcEgsGo/IpHLJbDqf0Kh0Sq1ar9isdsvter9UQmFMLpvP6AMgYAScB2CiGE2vnw+E4bwwcI/Z cUF7doR1cEECYwcIAWQAgYKKBJOUlZaXlQCJjkADZAQAA55jeZA+cwejhXUCAASqfD+OcwGbi6Y9 qLCrda5lpQh+BQEHY75jh7i6vKt4ZLd7or/FY7g8ywWumNuZZamfCNTDZgeNxtbYyU3CA5uhZH1v wsCB6VHU3wXi5c+b44rKFI0ScKCgwYKuEBJA2OnTmYVkAqiShswUtjrO9KEK4rDMsWw8/8TVGiPA okBCGVMGoTZomD9Ae95VrCdJlM2bNlFtBLJpEMVYPeaJpKkRp9EBOgH+MFdgENMCQMgIiEk0H8ak +oD4ETCRXUNk8+JcpJNyZ4+uipiWRBRRqtiTBQgeNHhMJY8Awpp+EqfulKOJYOwJwarvgD9S1D7i mXvwl7/AcPv61WgHVER/k5oB9iI4EmU0CeGpWtTSULFbnCPrAbgt76MyMLldagpZ3yjJuZ4xfhOM E4KFjIMzrJ0P9zVeXH/DPs4M0JfOQEqfSR4SXm5exrVIFPUK6ZDtR5E653HTB/jw5a2pX8++vfv3 8OPLn0+/vv37+PPr3++Dmf//AAYo4EGABBZoIDnCJajgggw26OCDEEYo4YQUVmjhhRhmqOGGHHbo 4YcghijiiCSWaOKJKKao4oostujiizDGKOOMNMYYAQA7 ------=_NextPart_000_0000_01C95AD5.CAAC4070 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/foi/graphics/mastheadart/images/fda_mast_bkgrd.gif R0lGODlhFQBEALMAAJmZzDMzZszM/2ZmmTMzmf////8AAMzMzAAAZgAAAAAAAAAAAAAAAAAAAAAA AAAAACwAAAAAFQBEAAAETNDISau9OOvNu/9gKIpIaZ5oqq5s675wLM90bd94ru987//AoHBILBqP yKRyyWwWntCodEqtTg/YrHbL7Xq/4LB4TC6bz+i0es1uoyMAOw== ------=_NextPart_000_0000_01C95AD5.CAAC4070 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/foi/graphics/mastheadart/images/fda_mast_02.gif R0lGODlhgAFEAPcAAP//////zP//mf//Zv//M///AP/M///MzP/Mmf/MZv/MM//MAP+Z//+ZzP+Z mf+ZZv+ZM/+ZAP9m//9mzP9mmf9mZv9mM/9mAP8z//8zzP8zmf8zZv8zM/8zAP8A//8AzP8Amf8A Zv8AM/8AAMz//8z/zMz/mcz/Zsz/M8z/AMzM/8zMzMzMmczMZszMM8zMAMyZ/8yZzMyZmcyZZsyZ M8yZAMxm/8xmzMxmmcxmZsxmM8xmAMwz/8wzzMwzmcwzZswzM8wzAMwA/8wAzMwAmcwAZswAM8wA AJn//5n/zJn/mZn/Zpn/M5n/AJnM/5nMzJnMmZnMZpnMM5nMAJmZ/5mZzJmZmZmZZpmZM5mZAJlm /5lmzJlmmZlmZplmM5lmAJkz/5kzzJkzmZkzZpkzM5kzAJkA/5kAzJkAmZkAZpkAM5kAAGb//2b/ zGb/mWb/Zmb/M2b/AGbM/2bMzGbMmWbMZmbMM2bMAGaZ/2aZzGaZmWaZZmaZM2aZAGZm/2ZmzGZm mWZmZmZmM2ZmAGYz/2YzzGYzmWYzZmYzM2YzAGYA/2YAzGYAmWYAZmYAM2YAADP//zP/zDP/mTP/ ZjP/MzP/ADPM/zPMzDPMmTPMZjPMMzPMADOZ/zOZzDOZmTOZZjOZMzOZADNm/zNmzDNmmTNmZjNm MzNmADMz/zMzzDMzmTMzZjMzMzMzADMA/zMAzDMAmTMAZjMAMzMAAAD//wD/zAD/mQD/ZgD/MwD/ AADM/wDMzADMmQDMZgDMMwDMAACZ/wCZzACZmQCZZgCZMwCZAABm/wBmzABmmQBmZgBmMwBmAAAz /wAzzAAzmQAzZgAzMwAzAAAA/wAAzAAAmQAAZgAAMwAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAACwAAAAAgAFEAAAI/wBHCBxI sKDBgwgTKlzIsKHDhxAjSpxIsaLFixgzatzIsaPHjyBDihxJsqTJkyhTqlzJsqXLlzBjypxJs6bN mzhz6tzJs6fPn0CDCh1KtKjRo0iTKl3KtKnTp1CjSq1ZrarVq1izat3KtavXr2DDih1LtqzZs2jT ql3Ltq3bt3Djyp1Lt67du3jz6t3Lt6/fv4ADCx5MuLDhw4gTK17MuLHjx5AjS55MubLly5BXWQGs eRVmtlYCfR5NWm0gFgIE+A1kJbXn0mRZpxYNu/bYVbhxT26dWjXfQL0FvOaaO3fj4V5XBaetVndZ 54Sh1wUugIX12VWVV0fNYuvp7b2Zd//Vvt066vB3yf89j9wq6/PBU1tpX1iAeK+875vVvnksdf1+ nZfXKvAFgtwqwLEAYDUJupdad2Bp1hsLuH1nH169redaVgTCd2E1BMqHWINh/bcWdb6JdV5/Eb6F XG/0zYXiVgpupR1y3I2FnlWoLQiXgAFuuBVvKVZ1HoSF8RajViaa9iBZvLGYHJJrKXcVjHnNqFWN W1aHFYlh7VgVcD6+BWRf7HGl5ZVPFnZemVc1qVaPZHW4ZFbWuQVcnAJIadeaWHGZVZtXUvmVmFV9 aNeZfKXpXYZfIspZb36qiV1mXrKlXWCAXiUoVpBeZYWhXkkaGl6MnnVnV44yGSqbmQr/hmKRXcmZ nVur1kmoVbnSmBquZXXK44KUYiXdoZfeGid882kloXwxPtvnq97BRyGfIBKpn7SjCunqr1kRORyB nlFnnnWvjWoeckR+2lW33kb64JuidmchktqGS2VrIB55H4HMaWatgRMGYuCYvtE7poe0FWgwwlnd u22N9+YqrJELMpuWmFZIqWQ1H/N5oa0MYhciuDZuaO7CrsWnKIgiVgPfnRejKBqCrs0qbnYoDpej duZVeqXNXUKYb8nVEfmkhx8+C6GF5O0oW9PVecYf0/adLHNw/Y6c4awPWnhViN2RzWt+Ssf6KMqB LjjrtWaJKWh+PHorJ93ZxYw0rSK//wb03tXRxhuSf+cdr7x8wxz2ctPO1urWwhl5qbkPPwo5qYzS 6+G1OiMMbnDdpS34k7M2rGiDhSt9mrjJhgqp0p6i/HfU6Cr+csTUDssV03BuVSzIkStO5cqJels4 5C+yDarsbZInZaghSx78t4mTZ2+ByD+epnqGJ17v3vKKhzegR8L6GvHkBQw9dtThWHbzs+I2Iduu 048ydR5funNVeK/tvbtjc5nQSjU/IUVpeZEjXt0udLzieW9wvCLU4yDFvQXSLHcO9I2WgLMZ7als V1ja3c0Q9bgmNdBWjjoetUJlIvzFyWq7Kt/W4AMrq7zqTCH03NP0hrQyXUxmcGLaAP+5UrCQSWpF kLsPBA8Yuwcm63ipApICpXdB5dkQUlOkYhPLBcLDBfA1v7Nd+Aw3vGQhj4xXpBUL2RfGCKpNYZ57 HspuCK5OkYeLLyMZ4mjUO7ANUSs7Us4IDwdBSc0IjtKzUeX4J0HlAYmJFrSUFTOoQzzFK01TzCHu rEIkB6mth2j0pHhSSKgV3s9koDtQDM3IIPGsiY6+gSACRWMrPYrsf73rmiYJqCgWbEZYPdulenaZ Kq60a4GBAhciz+g/37Upi8zUYgMxyCMK4WZ/shRlKD03SiGpUHlr/JAf3UilZSIuRbCUHuZEVEtW 7nFLuWQkD3nJnIcBE0bCxOfhisn/IesoMIqfY+Xj3mms30HTg8E7kwuJ6LKYyVCbwhNZN4P3TTWe 8nQug+Eb3clJCtWvSEB66ALtZUZbehKX3unSJ7siKfAh7o4FbZlAJ8mn98UKoL45ohdPSj3aHPSS 3tTfTiHWRAiJFJQRhagWk1oNU6aIZEqzaTk5GiLPfLSJ6rRkn5DKzVpRE4Awo08D6cmhXZoLprds 6ky95zmNIgmnDvTTQNOKOyH9dHrR/E+CVjUqrOzsqCbcFQqDGiunKpVXM2ugOW/kwDRiFXgrRU87 b0fQtjmLsmolFUMpi1ZOisiQT2oj5CRJGyg6Upm7imZdE/fQu+LIeOZZ5O78RLRO/wVWbYOlaCnB edHSJjNrq7xdRR2LTJfCipYl5ShPARmtlar1j7NU6X3oBUnpdTC11FRr8P552lhSa67LDaDdUqta R7UmnjDTT7F6JtFtcpWZw61hV/ckUcWutbRXLW5nxfhek3qOsvTl37UYu7x0wc2ZmJ0i9yroQDzi NUP0WZMstfZYoqXxWOFdoJSg2b8z4s84XglwE3PKw/y4tb2RZKph5/uyG6UuieIVJwVfN1rpiS9m ky2T9fDEopVlkYNxZOk8UwxZ5vRvodrFFz5X+8vgaAZev13gU8OD15Mi58fkVSDRoga6jGk2X/tL n4JOaEZSFpa3U/ZaGSEEo74icv/HJ7PPad60pzNNs7colmTgWDacGaGox7GCphup2rx55oipe1MQ 1soanzjbB1EhjFrHquPkfk7Iatn0rBWt9534cRl0jKYPkfoTnEkzbIrV3dGEcwjTkzW5lwldjnb9 5LKpzUZp8xFTk6KX6UxXy2UHTurbkrtVRguwaB32rC+H/DZXx0hpDj72OAFHoQ/HtKFh+xLTPtVs 5YwZYeeStaZDCDbXOJpggeOdoxUEtm0LEbIFnFC75txnSqWtdvBm4IRs11C4fadbcFu3gTbXOwQZ 7GAc+tfBYyRbY3FoSQbX8cGJY7DzNYvi4kEQiG8lnSsjnDUQf/id2iPWiruHTxn/RyKvxsbylrey tBeHjt/GtnEQHUjmVrt5yyNe8pw7nFcm51nAHkZyYwV95bzyubJsw/TDgIlNmm261KdO9cDQyZJR r7rWt851uHD06l0Pu9jHbpZDF5jsaE+72v3KSiCv/e1wD/ubMF3suNv97lK3UNJ6hfe++/3vgA+8 4AdP+MIb/vCAAYDiF8/4xjv+8ZCPvOQnT/nKW/7ymM+85jfP+c57/vOgD73oR0/60pv+9KhPvepX z/rWu370K4i97GdP+9rb/va4z73ud8/73vv+98APvvCHT/ziG//4yE++8pfP/OY7//nQj770p0/9 6lv/+tjPvva3z/3ue//74A+/T/jHT/7ym//86E+/+tfP/va7//3wj7/850//+tv//vjPv/73z//+ +///ABiAAjiABFiABniACJiACriADNiADviAEBiBEjiBFFiBFjh8AQEAOw== ------=_NextPart_000_0000_01C95AD5.CAAC4070 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/foi/graphics/mastheadart/images/fda_mast_03.gif R0lGODlhdABEALMAAP////8AAMzM/8zMzJmZzJmZmWZmmTMzmTMzZgAAZgAAAAAAAAAAAAAAAAAA AAAAACH5BAAAAAAALAAAAAB0AEQAAAT/MMhJq7046827/2AojmRpnmiqrmzrvnAsz3Rt33iu73yf JcCgcEgsGo/IpHLJbDqf0Kh0Sh0iqtis9gk4bL9g8ABQCJvPUQMAYEAY0PB4kbAeJOjFNUDu3PPn awQJagBXQ35+UIl9R4t/QWMAgoR2RImImJeICXqce2tBoJyjnkKioo9AkW+URpekn0Cxo6CbtrKl s7i0qUAIem90AJV5oZ61u52bvLTKuIu3qYRdCZGCXsWwps/c2tHJpOCOca0I1oMCrqjH7LKfr7OZ 2uGl9HHCdgfAd+tN471wzk27sqqIoUYA/xSkhOBAwSLYEkpUtcYLvkH7Jmo0oo8NP0kY/4cddGUM CbQo/3oRCjkp0JJXJudx2VhtWE07wgS9LInqVK5+PjWlVDKyypg3a5CCZKIHGbNYy2C+e0ozqacD HRk968Qu3i53XpdN/FUoq750/oyd5BWVp7evfxAQMDB3gIBTZLKmTYa3ntdQU2H1k3O3acUEHeXa pMn4V90BA9pQHHDAwF2djCcSGDCX45h0BZK6KTwXa+Z7hgcUiAhEmNI6hhcnKHpaCG0mBrBuNizZ 3STKQSy7PFQSC9ed5CLV8aJ8DVokV2A6OWhI+ulpw7AhKMxU7dZ6fumNC6rJHWDAQ58IH36UadO3 0aZC89mMW9huYKbdAd69G1S+fxH3HrM8zICFSRhqQPZcf2z9R1UXv2BDYHFvFbjNFwLsRgyDt/xV yx6/HHScM26Bp8xgRtmxygG31bZRe9Ns6GJmwx2w2owz6hFZizhuNA1mPQYp5JBEFmlkGLElqeSS TDbp5JNQRinllFRWaeWVUkKm5ZZcdunll2CGKeaYZJZp5plopqnmmmy26eabcMYp55x01mnnnXjm qeeefPbp55+ABirooIQWauihiCaq6KKMNuroo3RGAAA7 ------=_NextPart_000_0000_01C95AD5.CAAC4070 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/foi/HHS_blue_logo.gif R0lGODlhOQA8AMQAAKmiz/Dv99TQ5+Lg78XB34yEv5qTx29lr2FVpygYh0Q3l350t1NGn7ey1zYn jxoJgP///wAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAACH5BAAA AAAALAAAAAA5ADwAAAX/ICSOZGmeaKqubOu+cCzPdG3feK67gVAADYBhQBjsYgJDgQFIGBCAAiKJ WAgCRxUA0mAqFguDYGAQLg0KQ/YUQDDGQ5WgcRAQIIu1CED43WN9C1g7dlIAg0g/YToEAA4LRjZo A4NbNA0GCQWINgQHDxADD2oyQAUNRwMIEAgPDDICAAgFawMAD6MQli4FDn9Ztw8JAaK7K6oHnDoL uAkCEAoPqy+/OgGfDwrP2KQrAAfGOQHR2QHjuNMsCw7PhOQHEOcPyTzdOQIJuHn4uPC8Vzua4NpC IN+DPKhYDGAgSIeBZneCPdhyqxqKAQv84cDGDkKBZqgePrB44hRJGQEY/+BSgAWbMwjYFLSAchLG AHIIzJFjmXKlshQNItV4FwqnTnQ/UTDQSCMYLX7zIEBlyiJAOBmtEoQyuKWBQXstGKSjkQ8eti0f hV1VSKuGgIHQsnFp1i6GrJotCOB6houWypczDiDAyyKtVFx39NVoUKDtDGYOIOgdCQFXwhkNqvAg wJlzpqhvH9ByILpGgFMtBhjExTqBkdAEQl+mIVSFSNa4GESKJtORsKQuACwtLCYFg3yrQvuz1ThO VTC1SfTMBi76CNKUWx3EhluB2BWBUEjs7nyEyFXBHvXBTnfFacclABIwoJK80HwJTBngJIshcBR1 pRAAHbhJcwczCpAjzZwNBxwAlgpWKejKLyK9YsM1sQCiHToi6AXYhQsgQI9NG8aWAALW1eAgJDJ8 4kQCVOFwE0OEnYBAfrikeEMsJ8aYwgHOpPWgOKqoEtQKzFDEGgO61bJESgyUR0JoltTXpB5SCaDA N9oYoMR8B0zGkghjYFkCMQAIcIADmTVWQGgPPLKWmSMEUEQBneHRzCZ0ykBEn4AGKuighBZaaAgA Ow== ------=_NextPart_000_0000_01C95AD5.CAAC4070 Content-Type: text/css; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/stylesheets/news.css BODY { MARGIN-LEFT: 10%; COLOR: #000000; MARGIN-RIGHT: 10%; FONT-FAMILY: = Arial, Helvetica, sans-serif; BACKGROUND-COLOR: #ffffff } P { FONT-SIZE: 83% } H1 { MARGIN-TOP: 6px; FONT-WEIGHT: bold; FONT-SIZE: 140%; MARGIN-BOTTOM: = 6px; COLOR: #000080; FONT-STYLE: italic; BACKGROUND-COLOR: #ffffff; = TEXT-ALIGN: center } H2 { FONT-WEIGHT: bold; FONT-SIZE: 105%; TEXT-ALIGN: center } H3 { FONT-WEIGHT: bold; FONT-SIZE: 83%; MARGIN-BOTTOM: -8pt; TEXT-ALIGN: = left } .mainlist { FONT-SIZE: 83%; MARGIN-LEFT: 12pt; TEXT-ALIGN: left } A:hover { COLOR: #cc0000; BACKGROUND-COLOR: #ffffff } .center { TEXT-ALIGN: center } .header { MARGIN-TOP: 8px; FONT-SIZE: 75%; MARGIN-BOTTOM: 5px; TEXT-ALIGN: center } .footer { FONT-SIZE: 75%; TEXT-ALIGN: center } .small { FONT-SIZE: 75% } .hedbackground { BACKGROUND-IMAGE: url(/graphics/mastheadart/images/fda_mast_bkgrd.gif) } ------=_NextPart_000_0000_01C95AD5.CAAC4070--