Medical Action = Industries, Warning Letter

From: Subject: Medical Action Industries, Warning Letter Date: Mon, 3 Mar 2008 15:30:57 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0092_01C87D43.9375C970" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0092_01C87D43.9375C970 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6660c.htm Medical Action = Industries, Warning Letter

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Department of Health and Human Services

Public Health Service
Food and Drug = Administration

Atlanta District Office
60 Eighth Street, NE
Atlanta, GA = 30309

Telephone: 404/253-1161
FAX:=20 404/253-1201

January 24, 2008

VIA FEDERAL EXPRESS

Paul D. Meringola, CEO
Medical Action Industries
800 Prime=20 Place
Hauppauge, NY 11788

WARNING LETTER
(08-ATL-04)

Dear Mr. Meringola:

During an inspection of your firm located in Arden, North Carolina on = September 25 through October 9, 2007, an investigator from the United = States=20 Food and Drug Administration (FDA) determined that your firm = manufactures a=20 variety of medical procedure trays and kits. Under section 201(h) of the = Federal=20 Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products = are=20 devices because they are intended for use in the diagnosis of disease or = other=20 conditions or in the cure, mitigation, treatment, or prevention of = disease, or=20 are intended to affect the structure or function of the body.

The inspection revealed that these devices are adulterated within the = meaning=20 of section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used = in, or=20 the facilities or controls used for, their manufacture, packing, = storage, or=20 installation are not in conformity with the Current Good Manufacturing = Practice=20 (CGMP) requirements of the Quality System (QS) regulation found at Title = 21,=20 Code of Federal Regulations (C.F.R), Part 820. We = received a=20 response dated October 18, 2007 from Ms. Robin K. Blankenbaker, Director = of=20 Quality Assurance and Regulatory Affairs, concerning our = investigator=92s=20 observations noted on the Form FDA 483, List of Inspectional = Observations that=20 was issued to Ms. Blankenbaker at the close of the inspection. We also = received=20 a second undated response, which we will reference as the December = response. We=20 address these responses below, in relation to each of the noted = violations.=20 These violations include, but are not limited to, the following:

1. Failure to fully validate and document a process whose results = cannot be=20 fully verified by subsequent inspection and test, as required by 21 = CFR=20 820.75(a). Specifically,

A) No software validation or verification was available for the=20 [redacted] planning [redacted] = system which=20 is used for managing inventory, distribution of inventory, scheduling, = engineering change orders, recalls, complaints, reworks, device master = records, product return, procurement, production and sales processes. = You=20 provided some documented =93scenarios=94; however there was no = protocol or summary=20 included with those scenarios and no evidence that the tasks listed in = the=20 scenarios were ever performed.

We have reviewed your response received by the Atlanta District = office on=20 October 22, 2007 and have concluded that it is inadequate in that while = you=20 indicate that you have performed the [redacted] = software=20 verification, no documentation was provided. Documentation provided in = your=20 December response is incomplete and does not fully address software=20 verification. While various printouts of output testing were provided, = there was=20 no protocol one could follow to assess what your testing is actually=20 accomplishing.

B) You did not perform bioburden determination in the 2005 ethylene = oxide=20 (EO) validation study as specified in your protocol. The validation = for the EO=20 sterilization process was conducted in May 2005 in order to=20 [redacted]. As part of protocol # 797040273, your = firm was to=20 perform a bioburden evaluation study. The investigator was informed = that the=20 bioburden study was not done. The protocol emphasized the need to = perform=20 annual review of bioburden trends to ensure the continued = appropriateness of=20 the biological indicator.

Both your October and December responses are inadequate. Your = December=20 response provided a comparison of the 2004 and the 2007 bioburden data = which was=20 done on 10/18/07, after the completion of our inspection, on your = highest=20 bioburden (surgical gowns). Information provided in your December = response shows=20 that while bioburden for the surgical gowns was done in 2004, sterility = testing=20 done in 2005 (no documentation provided), there was no other bioburden = data for=20 the surgical gowns for 2006. The 2007 bioburden data for the surgical = gowns was=20 conducted after our inspection. Additionally your corrective action to = this=20 observation did not indicate that your firm was making a commitment to = perform=20 routine bioburden testing of the surgical gowns.

C) You have not performed product functionality and/or packaging = integrity=20 testing on post-sterilized products to assure conformance with product = specifications. You received customer complaints of liquids dry in = packages,=20 failing seals, and incorrect kit assembly. According to the = sterilization=20 validation protocol # 17-05-002, your firm was to conduct = functionality and/or=20 packaging integrity testing on the post-sterilized products to assure=20 conformance to specification. You did not conduct a formal study to = assess=20 product functionality and/or package integrity. You provided our = investigator=20 with a document showing that one case out of a = [redacted]=20 pallet load was visually checked. The document was incomplete and did = not have=20 enough information to show what was checked. You did not conduct any = QA=20 inspections prior to the release of the lot and also no inspections = are done=20 post sterilization of the lot.

We reviewed your October response and determined that it was = incomplete in=20 that you did not provide any evidence of product functionality or = package=20 integrity testing. Your December response was inadequate in that no = statistical=20 rationale was provided for packaging evaluations. You did not = specifically=20 indicate how you were going to address product functionality.

2. Failure to review, evaluate, and investigate where necessary = complaints=20 involving the possible failure of a device to meet any of its = specifications,=20 as required by 21 CFR 820.198(c). Specifically, customer complaint = #20000667=20 dated 8/6/07 indicated that Laceration Kits (Product #57877) were = gamma=20 sterilized and resulted in rusty instruments and discolored medicine = cups. The=20 lots in inventory were placed on hold. Your firm=92s investigation = into this=20 matter indicated that the needles cannot be gamma sterilized. You = subsequently=20 re-sterilized the affected lots which were still in inventory by EO=20 sterilization. This action was taken by your firm=92s product family = coordinator=20 who is an administrative support person. Information in the complaint = file=20 indicated that the sales representative will work with the customer to = determine the disposition of the product already in the field. As of = the start=20 of our inspection, your firm did not have any documentation of = customer=20 contact or your firm=92s response to the customer. During the = inspection, our=20 investigator asked whether other customers were affected and was told = that=20 only one customer had received the affected product.

Your responses are inadequate in that you did not identify a root = cause for=20 the discolored medicine cups and rusty instruments. While your October = response=20 indicates that this was an isolated case, your December response = indicates that=20 your firm received one other complaint for rust on instruments in 2007. =

3. Failure to establish and document corrective and preventive = action=20 activities, including analysis of sources of quality data, = investigations of=20 causes of nonconformities, verification and validation of corrective = actions,=20 and the implementation of corrective and preventive actions, as = required by 21=20 CFR 820.100. You have not established a formal corrective and = preventive=20 action system. You received at least 5 confirmed complaints on Lot = TL6090201=20 of Alcohol Prep Pads which had an =93unpleasant odor=94. You did not = determine a=20 root cause for these complaints. A Supplier Corrective Action Report = (SCAR)=20 was to be sent to the vendor, however, the complaint record shows that = no SCAR=20 was sent and that the supplier had indicated to you that they received = a batch=20 of =93funny smelling=94 isopropyl alcohol. No formal investigation was = made to=20 determine whether the alcohol was within specifications and if = impurities were=20 present.

We reviewed your October response which indicates that you now have a = new=20 procedure for CAPA documentation. The CAPA system in place during our = inspection=20 was not robust enough to capture all CAPA activities. We will review the = adequacy of your new CAPA procedure during our next inspection.

4. Failure to establish and implement sampling plans based on a = valid=20 statistical rationale, as required by 21 CFR 820.250(b). You did not = have a=20 rationale for the number of packages which are visually inspected = every=20 [redacted] hours on the [redacted] = packaging=20 machines. Out of [redacted] IV kits reviewed under = work order=20 #21470, a total of 6 packages were evaluated. There were no additional = inspections or evaluations performed on these packages either pre or = post=20 sterilization before the work order was released.

Your October response indicated that all packaging machines have been = validated. This was not the case during our inspection. You indicated = that=20 according to your sampling procedure, [redacted] from = each=20 cavity of the die is visually inspected and tensile strength testing is = done at=20 the start of each work order and, at a minimum every = [redacted]=20 hours. Our investigator noted that in some cases tensile strength = testing is=20 done and in some cases only visual inspection is done. You still have = not=20 provided a rationale/justification for your sampling.

5. Failure to establish and maintain procedures to control product = that=20 does not conform to specified requirements, as required by 21 CFR = 820.90(a).=20 You have not established procedures for identifying, segregating, and = handling=20 non-conforming products.

Your response indicates that your firm now has a written procedure = for=20 addressing non-conforming product. This response appears adequate and = will be=20 evaluated during our next inspection.

6. Failure to ensure that all employees have the necessary training = and=20 experience to perform their jobs, as required by 21 CFR 820.25 (b).=20 Specifically employees who manage, perform, and assess work affecting = quality=20 have not been adequately trained as members of your firm=92s quality = unit.=20 Quality Assurance employees have not performed effectively in = conducting=20 complaint investigations, corrective/preventive action activities, = design=20 activities, internal audits, risk analysis and/or document reviews. = You ran=20 out of existing safety pins for the circumcision tray and a larger = safety pin=20 was substituted. You received at least two customer reports of = excessive=20 bleeding. The change to the larger safety pin was made by the Product = Family=20 Coordinator (PFC). The product authorization form was not signed and = did not=20 proceed through the change process. Other examples of inadequate = employee=20 training are the failure to implement adequate corrective and = preventive=20 actions to complaints of crystallizing alcohol in kits and a complaint = of weak=20 seals.

Your October response is inadequate in that there were no commitments = to=20 improve employee training. Your December response appears adequate. We = will=20 evaluate the adequacy and effectiveness of your employee training during = our=20 next inspection.

7. Failure to conduct management review at defined intervals, as = required=20 by 21 CFR 820.20 (c). Specifically, you have not conducted management=20 reviews [redacted] of 2007 as per your SOP # = 1-QA-0107=20 (Management Review). There were no management review attendance = documents=20 available to show the quality system=92s review for this year. =

Your October response appears adequate and will be evaluated during = our next=20 inspection.

8. Failure to conduct quality audits to verify that the quality = system is=20 effective in fulfilling the quality system objectives, as required by = 21 CFR=20 820.22. You had not audited several key areas of your quality system = such as=20 environmental controls, acceptance activities, sterilization, labeling = and=20 packaging, storage, and distribution. In addition, your procedures for = quality=20 audits were not complete in that they did not include an audit = frequency.=20

Your October response is inadequate in that audits of the subsystems=20 identified in the first 3 quarters of 2007 indicate the due dates with = no=20 documentation that such audits were conducted. Your December response = still=20 indicates that many of the QSR areas to be audited have not been = audited.

Our inspection also revealed that your devices are misbranded under = section=20 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or = refused=20 to 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-Medical Device=20 Reporting (MDR) regulation. Significant deviations include, but are not = limited,=20 to the following:

Failure to develop, maintain, and implement written MDR procedures to = provide=20 for: (1) Timely and effective identification, communication , and = evaluation of=20 events that may be subject to MDR requirements; and (2) A standardized = review=20 process or procedure for determining when an event meets the criteria = for=20 reporting under 21 CFR Part 803, as required by 21 CFR 803.17(a). You = had not=20 established MDR procedures and there is no internal system which = provides for a=20 standardized review process for determining when an event meets the = criteria for=20 reporting. Complaint #200000300 in which an x-ray detectable sponge = reportedly=20 disintegrated while in the patient, and complaint #200000447 which = indicated=20 that two patients experienced redness, erythemia and blisters at their = central=20 line placement site from the use of the new [redacted] = dressing=20 were not investigated.

Your responses are inadequate in that you made no attempt to get = additional=20 patient information with respect to these complaints. There is no = documentation=20 to show any contact with the health care providers or patients to obtain = additional information about these complaints.

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 FDA without further notice. These actions = include, but=20 are not limited to, seizure, injunction, and/or civil money penalties. = Also,=20 federal agencies are advised of the issuance of all Warning Letters = about=20 devices so that they may take this information into account when = considering the=20 award of contracts. Additionally, premarket approval applications for = Class III=20 devices to which the Quality System regulation deviations are reasonably = related=20 will not be approved until the violations have been corrected. Requests = for=20 Certificates to Foreign Governments will not be granted until the = violations=20 related to the subject devices have been corrected.

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, including an explanation of how you plan to = prevent these=20 violations from occurring again. Include documentation of the corrective = action=20 you have taken. If your planned corrections will occur over time, please = include=20 a timetable for implementation of those corrections. If corrective = action cannot=20 be completed within 15 working days, state the reason for the delay and = the time=20 within which the corrections will be completed. Please send your = response to=20 Serene N. Ackall, Compliance Officer at 60 Eighth Street, NE, Atlanta, = GA 30309.=20 If you have any questions about the content of this letter please = contact Serene=20 N. Ackall at 404-253-1296.

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 = responsibility=20 to ensure compliance with applicable laws and regulations administered = by FDA.=20 The specific violations noted in this letter and in the Inspectional=20 Observations, Form FDA 483 (FDA 483), issued at the closeout of the = inspection=20 may be symptomatic of serious problems in your firm=92s manufacturing = and quality=20 assurance systems. You should investigate and determine the causes of = the=20 violations, and take prompt actions to correct the violations and to = bring your=20 products into compliance.

Sincerely,

/S/

Mary H. Woleske
District Director

Cc: Ms. Robin K.=20 Blankenbaker
Director of Quality Assurance and Regulatory = Affairs
Medical=20 Action Industries, Inc.
25 Heywood Rd.
Arden, NC 28704-9302 =

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FDA/Freedom=20 of Information

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