MRL, Inc:, a = Welch Allyn Company Warning Letter

From: Subject: MRL, Inc:, a Welch Allyn Company Warning Letter Date: Sun, 2 Mar 2008 09:57:46 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_000F_01C87C4B.DD952670" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_000F_01C87C4B.DD952670 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/archive/g6173d.htm MRL, Inc:, a = Welch Allyn Company Warning Letter

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	Chicago District 550 West Jackson Blvd., 15th = Floor Chicago,=20 Illinois 60661 Telephone: = 312-353-5863

WARNING = LETTER
CHI-2-07

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Mr. James P. Fee, Jr., President
MRL, Inc:, a Welch Allyn = Company
1000=20 Asbury Drive Suite 17
Buffalo Grove, IL 60089

Dear Mr. Fee:

United States Food and Drug Administration (FDA) investigators = conducted an=20 inspection of your firm located in Buffalo Grove, IL, from May 22 = through July=20 20, 2006. The investigators determined that your firm manufactures = automatic=20 external defibrillators. Under Section 201(h) of the Federal Food, Drug, = and=20 Cosmetic Act (the Act) [21 U.S.C. 321(h)], these products are devices = because=20 they are intended for use in the diagnosis of disease or other = conditions or in=20 the cure, mitigation, treatment, or prevention of disease, or are = intended to=20 affect the structure or function of the body.

This inspection revealed that these devices are adulterated within = the=20 meaning of Section 501(h) of the Act [21 U.S.C. 351(h)], in that the = methods=20 used in, or the facilities or controls used for, their manufacture, = packing,=20 storage, or installation are not in conformity with the current Good=20 Manufacturing Practice (cGMP) requirements of the Quality System (QS) = regulation=20 found at Title 21, Code of Federal Regulations (CFR), Part 820. We = received=20 three monthly responses from Kevin Cahill, Executive Vice President, and = Chris=20 Horacek, Office of the President, dated August 11, 2006, September 14, = 2006 and=20 October 31, 2006. The responses were directed to our investigators' = observations=20 noted on the FDA 483, Inspectional Observations, that was issued to you. = We=20 address your responses below, after the description of the deficiencies. = These=20 deficiencies include, but are not limited to, the following:

1. Failure to establish and maintain procedures for implementing = corrective=20 and preventive actions. The procedures must include verifying or = validating the=20 corrective. and preventive actions to ensure that such actions are = effective and=20 do not adversely affect the finished device, as required by 21 CFR=20 820.100(a)(4). For example, the corrective action of adding=20 [redacted] to the [redacted] socket = during=20 manufacturing and servicing of PIC 50 and AED 20 has not been verified = or=20 validated as to be effective in preventing an unacceptable delay or = prevent the=20 delivery of therapy.

Your response to FDA-483 Observation # 1 appears to be adequate .

2. Failure as a manufacturer to establish and maintain procedures for = verification of your device's design. Design verification must confirm = that the=20 design output meets the design input requirements . The results of the = design=20 verification, including identification of the design, methods, the date, = and the=20 individuals performing the verification, must be documented in the = device=20 history file, as required by 2 .1 CFR 820 .30(f) . For example, the = .vibration=20 test method used in the design verification was not the test listed in = the=20 product specifications.

We have reviewed your response to FDA-483 Observation # 2 and have = concluded=20 that it is inadequate. You have responded only to the example described = in the=20 FDA-483. This example demonstrates to us that your firm needs to conduct = a=20 global review of other specifications and products.

3. Failure to maintain complaint files. As a manufacturer you must = establish=20 and maintain procedures for receiving, reviewing, and evaluating = complaints for=20 a formally designated unit. Such procedures must ensure that any = complaint=20 involving the possible failure of a device, labeling, or packaging to = meet any=20 of its specification must be reviewed, evaluated and investigated, = unless such=20 investigation has already been periormed for a similar complaint and = another=20 investigation is not necessary, as required by 21 CFR 820.198(c). For = example, a=20 complaint involving a PIC 50 was not investigated or a follow-up was not = made to=20 find out if devices treated with [redacted] a terminal = cleaner=20 /protectant designed to help prevent corrosion from forming on metal to = metal=20 contacts, was affected by corrosion.

Your response to FDA-483 Observation # 3 appears to be adequate.

4. Medical Device Reporting (MDR): Failure to maintain complaint = files. As a=20 manufacturer you must establish and maintain procedures for receiving,=20 reviewing, and evaluating complaints by a formally designated unit. Such = procedures must ensure that any complaint that represents an event which = must be=20 reported to FDA under 21 CFR 803 will be investigated by a designated = individual=20 and will be maintained in a separate portion of the complaint files or = otherwise=20 clearly identified, as required by 21 CFR 820.198(d). For example, a = complaint=20 involving an MDR reportable death event was reported to your firm. The = complaint=20 about the PIC 50 device involved in that complaint was received on = 6/25/04, and=20 a formal complaint investigation was not initiated until 10/08/04, = nearly four=20 months later. FDA sent your firm a letter on 8/20/2004 requesting = additional=20 information concerning the referenced incident . The FDA letter gave a = time=20 frame of 45 days of receipt of the letter to respond. Your firm's = response=20 letter was dated 10/14/04 which was 55 days from the receipt of the FDA = letter,=20 making it 10 days beyond the requested response date.

We have reviewed your response FDA-483 Observation # 5 and have = concluded=20 that it is inadequate because of your failure to follow your CAPA 455Q, = which=20 addresses the filing of late MDRs. In your response, your effectiveness = checks=20 covered only 3 months, not the 6 months time frame stated in your CAPA = 455Q.

5. Failure to have established nonconformity review and disposition = of=20 manufactured devices: Each manufacturer must establish and maintain = procedures=20 that define the responsibility for review aiid authority for the = disposition=20 .of nonconforming product. The procedures must set forth the review = and=20 disposition process. Documentation must include the justification for = use of=20 nonconforming product and signature of individuals authorizing the = use, as=20 required by 21 CFR 820.90(b)(1). For example, conclusions were = documented on a=20 complaint investigation by a quality consultant who had neither the=20 responsibility, evidence, background training, or experience to make = such a=20 conclusion.

Your response to FDA-483 Observation # 7 appears to be adequate.

6. Failure to establish and maintain instructions and procedures = for=20 performing and verifying that servicing meets the specified = requirements, as=20 required by 21 CFR 820.200(c). Each manufacturer who receives a = service report=20 that represents an event which must be reported to FDA under 21 CFR = 803, must=20 automatically consider the report a complaint and must process it in=20 accordance with the requirements of 820.198. For example, two repair = orders,=20 R24951 (dated 02/07/2006, AED 20 device, S/N = [redacted]) and=20 R23948 (dated 03/07/2006, AED 20 device, S/N = [redacted], were=20 confirmed to have "Defib Comrin Fail". These repair orders were not = evaluated=20 to determine if they were MDR reportable events at the time of = servicing, even=20 though similar failure modes have been reported by your firm,in other = MDR=20 reports.

Your response to FDA-483 Observation # 9 appears to be adequate.

7. Failure to establish and maintain instructions and procedures = for=20 performing and verifying that servicing meets the specified = requirements, as=20 required by 21 CFR 820.200(a). Each manufacturer must establish and = maintain=20 instructions and procedures for performing and verifying that = servicing meets=20 specified requirements. For example, service procedures were not = implemented=20 for MDR 1418729-2004-00009. The date and signature of the person who = decided=20 to complete this form were not documented and the signature of the = person who=20 decided not to complete an MDR reportable event record in a repair = order=20 number R21591 was not documented.

Your response to FDA-483 Observation # 10 appears to be adequate.

8. Failure to investigate the cause of nonconformities relating to = product,=20 processes, and the quality system, as required by 21 CFR 820.100a)(2). = For=20 example, the following procedures, Complaint Handling, Defect Tracking = and=20 Trending, Nonconforming Material and Repair of Equipment, do not = include=20 procedures for performing failure investigations.

Your response to FDA-483 Observation # 11 appears to be adequate.

9. Failure to analyze processes, work operations, concessions, = quality=20 audit reports, quality records, service records, complaints, returned = product,=20 and other sources of quality data to identify existing and potential = causes of=20 nonconforming product , or other quality problems, as required by 21 = CFR=20 820.100(a)(1). For example, procedures for Corrective and Preventive = Action,=20 Complaint Handling, Tracking and Trending, and Statistical Techniques = and=20 Analysis of Data, do not contain a list of maintained databases for = collecting=20 failure data or the requirements for how those databases should be = maintained=20 and evaluated.

We have reviewed your response to FDA-483 Observation # 12 and = conclude that=20 the plan was adequate; but without completion of the databases we have = no=20 assurance that its implementation will be adequate.

10. Failure to have production and process controls for automated=20 processes, as required by 21 CFR 820.70(i). when computers or = automated data=20 processing systems are used as part of production or the quality = system . A=20 manufacturer is required to validate computer software for its = intended use=20 according to an established protocol. For example, databases that are=20 maintained for data analysis and other tracking and trending = functions,=20 including complaint and services access databases, have riot been = validated=20 for their intended use.

We have reviewed your response to FDA-483 Observation # 13 and = conclude that=20 it is inadequate because, without completion of the validation, we have = no=20 assurance that it will be adequate.

11. Failure to establish and maintain instructions and procedures = for=20 performing and verifying that servicing meets the specified = requirements, as=20 required by 21 CFR 820.200(b). Each manufacturer must analyze service = reports=20 with appropriate: statistical methodology in accordance with Section = 820. 100.=20 For example, your quality group reviews narrative summaries of service = reports=20 every two weeks, but the data is not tracked and trended according to = a=20 statistical method.

We have reviewed your response to FDA-483 Observation # 14 and have = concluded=20 that it is inadequate because it is not clear if the old. data is going = to be=20 merged in the new validated database when it becomes available.

12. Failure as a manufacturer to establish procedures for = identifying=20 training needs and to ensure that all personnel are trained to = adequately=20 perform their assigned responsibilities. Training must be documented, = as=20 required by 21 CFR 820.25(b). For example, the current Complaint = Coordinator=20 was documented as an initiator and evaluator for complaint closure = before=20 being trained for that job. Also, the current Service Manager has been = working=20 at the company for approximately 12 years, and .that employee has = never been=20 trained in the most current Document Control. procedures . Also, the = current=20 Material Manager has no training documentation that provides a = description of=20 the verification method used to measure training effectiveness for the = following subjects: returned goods to stock; corrective and preventive = action=20 (CAPA); FORMS; and, Operations Standard Operating = Procedures.

Your response to FDA-483 Observations # 16 and # 17 appears to be=20 adequate.

13. Failure to have control of nonconforming manufactured product. = Each=20 manufacturer must establish and maintain procedures to control product = that=20 does not conform to specified requirements. The procedures must = address the=20 identification, documentation, evaluation, segregation, and, = disposition of=20 nonconforming product, as required by 21 CFR 820.90(a). For example, = we=20 determined that, for nonconforming material reports for returning = components=20 to vendors. for investigation, the supplier corrective action response = Section=20 of the nonconforming report was not always completed. =

We have reviewed your response to FDA-483 Observation # 18 and have = concluded=20 that it is inadequate because, while the actual Supplier's Corrective = Action=20 Request (SCAR) has been completed, two other corrective actions, = including=20 evaluation of the SCARs dating back to April 2003, and review of SOP's = for=20 appropriateness, have not been completed.

14. Failure to maintain complaint files. As described above, you must = establish and maintain procedures for receiving, reviewing, and = evaluating=20 complaints for a formally designated unit. Such procedures must ensure = that: all=20 complaints are processed in a uniform and timely manner; oral complaints = are=20 documented upon receipt; and complaints are evaluated to determine = whether they=20 represent an event which is required to be reported under 21 CFR 803, as = required by 21 CFR 820.198(a). For example, the current compliant = handling=20 procedure does not reference a Failure Investigation SOP as an = associated=20 document and does not address when and how to reply to the complainant = when an=20 investigation is conducted. Also; your complaint # 2005011181 does not = have the=20 MDR number filled in and the investigation required field was not = checked.=20 Complaint # 20510271 did not have the corrective and preventive action = (CAPA)=20 information.

Your response to FDA-483 Observations # 19 and # 25 appears to be=20 adequate.

15. Failure to implement and record changes in methods and procedures = needed=20 to correct and prevent identified quality problems, as required under 21 = CFR=20 820.100(a)(5). For example, a corrective action plan was created to = change; the=20 method used in the service department to store components that were = removed from=20 devices. Changes were recorded, but the written procedures were not = updated with=20 current changes.

Your response to FDA-483 Observation # 21 appears to be adequate.

16. Failure to follow document controls requirements. Each = manufacturer=20 must establish and maintain procedures to control all documents that = are=20 required by 21 CFR 820.40. For example, after the original signed and=20 initiated Corrective and Preventive action (CAPA) 440C document was = lost, a=20 rewritten CAPA 440C document was not filed until nearly one year=20 later.

We have reviewed your response for FDA-483 Observation # 22 and have=20 concluded that it is inadequate because the required corrective and = preventive=20 action has not been completed.

17. Failure to document corrective and preventive action activities = and=20 their results, as required by 21 CFR 820.100(b). For example, the = rewritten=20 CAPA 440C form was incomplete. Two things were missing. The first was = that the=20 type of action was not checked as corrective or preventive action. The = second=20 was that verification or validation is required and no documentation = was=20 attached or referenced to CAPA 440C.

We have reviewed your response for FDA-483 Observation # 23 and have=20 concluded that it is inadequate because the new rewritten CAPA 440C was=20 incomplete, and no referenced documentation was attached for review to = indicate=20 verification and validation was completed.

18. Failure io identify the actions needed to correct and prevent=20 recurrence of nonconforming product and ottier quality problems as = required in=20 21 CFR 820.100(a)(3). For example, your firm's rewritten CAPA 440C did = not=20 address quality problems identified in complaint #200510271. That = complaint=20 involved product lost in the material review board's area, but CAPA = 440C=20 addresses product stored in the service department. Also, the = rewritten CAPA=20 440C references the wrong complaint number, not = #200510271.

We have reviewed your response for FDA-483 Observation # 24 and have=20 concluded that it is inadequate because your firm had already determined = that a=20 CAPA was warranted. Your firm has not appropriately documented the = corrections=20 taken in response to the issues that arose during this complaint=20 investigation

Our inspection also revealed that your automatic external = defibrillator (AED=20 20) and portable intensive care system (PIC 50) devices are misbranded = under=20 Section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm = failed to=20 furnish material or information respecting; the device that is required = by or=20 under Section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 the = Medical=20 Device Reporting (MDR) regulation. Significant deviations include, but = are not=20 limited to, the following:

19. Failure to fulfill manufacturer's requirements. You must report = to FDA=20 no later than 30 days after the day that you receive or otherwise = become aware=20 of information, from any source, that reasonably suggests that a = device that=20 you market may have caused or contributed to a death or serious = injury, as=20 required by 21 CFR 803.50(a)(1). For instance, as an example of=20 non-compliance, an MDR report was not submitted to FDA within 30 days = after=20 your firm became aware of information that a PIC 50 had caused or = contributed=20 to a death of a patient.

We have reviewed ybur response to FDA-483 Observation # 4 and have = concluded=20 that it is inadequate because your failure to follow your CAPA 455Q, = which=20 addresses the filing of late MDRs. In your responses your effectiveness = checks=20 covered only 3 months, not the 6 months time frame stated in your CAPA = 455Q.

20. MDR reporting failure. When you obtained information required = under the=20 MDR regulation, you did not provide it timely because it was not known = or was=20 not available when you submitted the initial report. You are required = to=20 submit the supplemental information to FDA within one month of the day = that=20 you receive this information on a supplemental or follow up report, as = required by 21 CFR 803.56. For example, the supplemental report for = MDR=20 1418729-2005-00186, dated 10/27/2005, involving a patient's death, was = submitted to FDA on 3/23/2006, well after the one month time frame. = You also=20 failed to submit within one month a supplemental report for MDR=20 1418729-2005-00106 that should have included the complaint = investigation=20 information not provided in the original MDR.

We have reviewed your response FDA-483 Observation #' 6 and have = concluded=20 that it is inadequate because your failure to follow your CAPA 455Q, = which=20 addresses the filing of late MDRs. In your responses, your effectiveness = checks=20 covered only 3 months, not the 6 months time frame stated in your CAPA = 455Q.

21. Failure as a user facility, importer or manufacturer. You must = develop,=20 maintain, and implement written MDR procedures for intemal,systems = that=20 provide for timely and effective identification, communication, and = evaluation=20 of events that may be subject to MDR requirements, as required by 21 = CFR=20 803.17. For example, two different MD R incidences, one with a PIC 50 = device=20 and the other with a AED-20, were given the same MDR number and = submitted to=20 the FDA. Also, your Quality system procedures do not address the = manner of=20 attempting to acquire patient identification information for the = Medwatch=20 form.

Yourresponse to FDA-483 Observation # 15 appears to be adequate.

22. Failure in your responsibility for obtaining and submitting to = FDA=20 information that is incomplete or missing'from reports submitted by = user=20 facilities, importers, and other initial reporters, as required by 21 = CFR=20 803.50(b)(2). For example, three MDR reports did not include patient=20 information and no steps were documented as taken to assure that such=20 information would be attempted to be acquired.

Your response to FDA-483 Observation # 20 appears to be adequate.

We will not be able to verify fully the sufficiency of all your = responses=20 until the next inspection. As you have promised, however, please = continue to=20 provide updates, if applicable, on the status of corrective actions you = have=20 taken. 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, = injunction,=20 and/or civil money penalties. Also, federal agencies are advised of the=20 issuance,of all Warning Letters about devices so that they may take this = information into account when considering the award of contracts. = Additionally,=20 premarket approval. applications for Class III devices to which the = Quality=20 System regulation deviations are reasonably related will not be approved = until=20 the violations have been corrected. Requests for Certificates,to Foreign = Governments will not be granted until the violations related to the = subject=20 devices have been corrected.

Please notify this office in writing within 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 action you have taken. If your planned corrections = will occur=20 over time, please include a timetable for implementation of those = corrections.=20 If corrective action cannot be completed within 15 working days, state = the=20 reason for the delay and the time within which the corrections will be=20 completed.

Your response should be sent to: Matthew J. Sienko Compliance Officer = at 550=20 West Jackson Blvd, 15th Floor, Chicago, Illinois 60661. If you have any=20 questions about the content of this letter please contact Mr. Sienko at = (312)=20 596-4213.

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

.
Sincerely,

/S/

Scott J. MacIntire
District Director

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FDA/Freedom=20 of Information

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