Cardinal = Health 414 LLC Warning Letter

From: Subject: Cardinal Health 414 LLC Warning Letter Date: Tue, 10 Jun 2008 14:39:09 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C8CB07.BE013960" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C8CB07.BE013960 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6788c.htm Cardinal = Health 414 LLC Warning Letter

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Department of Health and Human Services

Public Health Service
Food and Drug = Administration

Cincinnati District Office
Central Region
6751 Steger = Drive=20
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700

FAX: (513) 679-2771

May 28, 2008

WARNING LETTER
VIA FEDERAL EXPRESS

CIN-08-8546-17

John Rademacher
President
Cardinal Health 414 LLC
7000 = Cardinal=20 Place
Dublin, OH 43017

Dear Mr. Rademacher:

During an inspection of your firm located in Dublin, OH, on April 10 = through=20 15, 2008, an investigator from the United States Food and Drug = Administration=20 (FDA) determined that your firm is the specification developer and own = label=20 distributor of a point-of-use sharps container, called the Secure Safety = Insert=20 System. Under section 201(h) of the Federal Food, Drug and Cosmetic Act = (the=20 Act), 21 U.S.C. =A7 321(h), these products are devices because they are = intended=20 for use in the diagnosis of disease or other conditions, or in the cure, = mitigation, treatment, or prevention of disease, or are intended to = affect the=20 structure or function of the body.

This inspection revealed that the medical devices are adulterated = within the=20 meaning of section 501(h) of the Act, 21 U.S.C. =A7 351(h), in that the = methods=20 used in, or the facilities or controls used for manufacturing, packing, = storage,=20 or installation are not in conformity with the Current Good = Manufacturing=20 Practice (CGMP) requirements of the Quality System (QS) regulation found = at=20 Title 21, Code of Federal Regulations (CFR), Part 820. We received a = response=20 from William J. Northam, Director, Manufacturing Quality, dated April = 22, 2008=20 concerning our investigator's Form FDA 483 Observations (Form 483) that = was=20 issued to you at the close of the inspection. However, at this time we = cannot=20 evaluate the adequacy of your response because you are still in the = process of=20 developing procedures for the numerous proposed corrective actions that = you=20 estimated, in your response letter, would be completed by May 15, 2008. = These=20 violations include, but are not limited to, the following:

1. Failure to establish adequate management controls to ensure that = an=20 effective quality system has been established and maintained. [21 CFR = =A7=20 820.20] Specifically:

-Quality system procedures have not been established. [21 CFR =A7 = 820.20(e)] For example, there are no written corrective and = preventive=20 action procedures, design change control procedures, complaint = procedures,=20 and medical device reporting procedures.

-A management representative has not been appointed to ensure = that the=20 quality system requirements are met, and to report to management on = the=20 performance of the quality system. [21 CFR =A7 820.20(b)(3)]

-Management reviews do not ensure that the quality system = satisfies the=20 requirements of part 820 and your quality policy and objectives. [21 = CFR =A7=20 820.20(c)]

2. Failure to conduct quality audits to assure that the quality = system is=20 in compliance with the established quality system requirements and to=20 determine the effectiveness of the quality system. [21 CFR =A7 820.22] =

3. Failure to establish procedures for implementing corrective and=20 preventive actions; and failure to document corrective and preventive=20 activities, including analysis of quality data sources, investigations = of=20 causes of nonconformances, and implementation of corrective and = preventive=20 actions. [21 CFR=A7 820.100]

Specifically, your firm has not developed corrective and preventive = action=20 procedures. Additionally, your Director of Manufacturing Quality = stated that=20 the design of the sharp container cap was changed to allow the cap to = secure=20 tightly. This corrective and preventive action was not documented. =

4. Failure to establish complaint handling procedure for the = receiving,=20 reviewing, and evaluating complaints; and failure to evaluate = complaints. [21=20 CFR =A7 820.198(a)]

Specifically, your firm has not developed a complaint handling = procedure to=20 assure all complaints are documented, evaluated, and if necessary=20 investigated. For example, the four complaints that you received = concerning=20 needle sticks have not been evaluated and/or investigated to determine = if the=20 device caused or contributed to the needle stick.

5. Failure to establish procedures for acceptance and rejection of = incoming=20 product; and failure to perform acceptance activities, including = inspections,=20 tests, and other verification activities, for incoming products. [21 = CFR =A7=20 820.80(b)]

Specifically, your firm has not established procedures for the = acceptance=20 activities related to receipt of the Secure Safety Insert Systems, = which you=20 have contract manufactured Additionally, you do not perform any = testing on=20 these devices when they are received from the contract manufacturer. = You do=20 not have a written quality agreement nor do you receive a certificate = of=20 conformance from them.

6. Failure to establish design change control procedures for the=20 identification, documentation, validation and/or verification, review, = and=20 approval of design changes before implementation. [21 CFR =A7 = 820.30(i)]

Specifically, between 2003 and 2006, design changes were made to = the Secure=20 Safety Insert System. The molding operation was changed to improve the = visibility of the biohazard symbol on the cap; the interlock of the = cap into=20 the tube was changed to improve the pull strength testing; and short = caps were=20 added to accommodate different size syringes. Verifications and/or=20 validations, design reviews, design releases, and design approvals = were not=20 performed for any of these changes.

The inspection also revealed that your devices are misbranded under = section=20 502(t)(2) of the Act, in that your firm failed to develop written = Medical Device=20 Reporting procedures as required by 21 CFR 803.17.

You should take prompt action to correct the violations addressed in = this=20 letter. Failure to promptly correct these violations may result in the=20 initiation of regulatory action without further notice. This may = include, but is=20 not limited to, seizure, injunction, and/or civil money penalties. Also, = federal=20 agencies are advised of the issuance of all Warning Letters about = devices so=20 that they may take this information into account when considering the = award of=20 contracts. Additionally, premarket applications for Class III devices to = which=20 the Quality System regulation deviations are reasonably related will not = be=20 approved until the violations have been corrected. Requests for = Certificates to=20 Foreign Governments will not be granted until the violations related to = the=20 subject devices have been corrected.

Please notify this office within fifteen (15) working days from the = date you=20 receive this letter of the specific steps you have taken to correct the = noted=20 violations, including an explanation of how you plan to prevent these=20 violations, or similar violations, from occurring again. Include = documentation=20 of the corrective actions you have taken. If your planned corrective = actions=20 will occur over time, please include a timetable for implementation of = those=20 corrections. If corrective action cannot be completed within 15 working = days,=20 state the reason for the delay and the time within which the corrections = will be=20 completed.

Your response should be sent to Ms. Gina Brackett, Compliance = Officer, Food=20 and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If = you have=20 any questions about this letter, you may contact Ms. Brackett at (513) = 679-2700,=20 ext. 167, or you may forward a facsimile to her at (513) 679-2773.

Finally, you should know that this letter is not intended to be an=20 all-inclusive list of violations at your facility. It is your = responsibility to=20 ensure compliance with applicable laws and regulations administered by = the FDA.=20 The specific violations noted in this letter and in the FDA 483s may be=20 symptomatic of serious problems in your firm's manufacturing and quality = assurance systems. You should investigate and determine the causes of = the=20 violations, and take prompt action to correct the violations and to = bring your=20 products into compliance.

Sincerely,

/S/

Carol A. Heppe
District Director
Cincinnati District

cc: R. Kelly Clark
Cardinal Health Inc.
President and CEO =
7000=20 Cardinal Place
Dublin, OH 43017

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FDA/Freedom=20 of Information

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