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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Plastics Management Corporation 4/25/07

Department of Health and Human Service's Eagle LogoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX : (513) 679-2771


 

April 25, 2007

WARNING LETTER
CIN-07-32743-15

VIA FEDERAL EXPRESS
 

Mr. Phillip Kamins, Owner
Plastics Management Corporation
12243 Branford Street
Sun Valley, CA 91352

Dear Mr. Kamins:

During an inspection of your medical device manufacturing facility, Kentucky Packing Service, LP, DBA Olsen Medical, located at 3001 West Kentucky Street, Louisville, Kentucky, on February 7 through 28, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm at this location is the manufacturer of sterile and non sterile electrosurgical devices, such as bipolar and monopolar forceps, pens/pencils, and electrodes. Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended 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 structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received two response letters from John P. Waters, Quality Assurance/Regulatory Affairs Manager, dated March 30, and April 3, 2007 concerning our investigator's observations noted on the Form FDA-483, List of Inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1) Failure to implement your procedures for "Sterility Dose Monitoring" to ensure that the parameters established during gamma sterilization validation continue to meet required specifications. [21 CFR 820.75(b)]

Specifically, your procedure requires that all sterilized medical devices meet the specifications of [redacted] Between 2002 and 2005, there were eight quarterly dose audits that did not meet test acceptance criteria, and the [redacted] requirements were not followed. For example, the sterility test performed after the quarterly dose audit for forceps (family group #[redacted]) in March of 2004 found 14 positive articles out of 100. The [redacted] document requires that the sterilization dose be re-established and an investigation be performed if there has been a significant increase in the bioburden estimate. The bioburden had increased by 150 CFUs from the previous dose audit and your firm did not re-establish the sterility dose and did not investigate the cause of the increase in bioburden.

Additionally, between June of 2004 and July of 2005, the quarterly dose audits were not performed.

Your response to this observation appears adequate. We will verify the adequacy of your corrective action during a future inspection.

2) Failure to fully validate the change in your sterilization process. [21 CFR 820.75(a)]

Specifically, your firm conducted a study to validate an increase in the routine sterilization dose delivered for family group [redacted] (scratch pads). Your validation did not include functionality testing of the devices to assure the higher dose did not affect the performance of the device. Your validation protocol, "Quality Plan 40", did not establish acceptable and unacceptable results.

We have reviewed your response and have concluded that is inadequate because your revised QAPO10 procedure only addresses dose augmentation when a quality dose audit fails. For family group #[redacted] (Scratch pads), the reason that your firm changed the dose was for cost reasons, not for failures. Your procedure does not address other reasons for changing the dose. Additionally, your response does not address whether or not your firm is planning on revalidating the sterilization process for family group #[redacted] and what functionality testing will be performed.

3) Failure to assure that devices meet all final acceptance criteria prior to distribution. [21 CFR 820.80(d)]

Specifically, during the testing of three different lots of Pott-Smith forceps, 34 of the 150 forceps tested failed the resistance test. All of these forceps had a reading greater than your tolerance of less than or equal to [redacted] There is no documentation that these forceps were reworked and retested. All of these forceps were released for distribution.

Your response to this observation appears adequate. We will verify the adequacy of your corrective action during a future inspection.

4) Failure to review all associated data and documentation prior to distributing finished devices. [21 CFR 820.80(d)(2)]

Specifically, for five of the twenty device history records reviewed by the FDA Investigator for the Jeweler's Kit devices, the devices were released for distribution prior to subassemblies, which were included in these lots, being reviewed and released. For example, finished device lot #[redacted] was released on April 27, 2006, but a subassembly that was used in this device, lot #[redacted], was not released until May 2, 2006.

Your response to this observation appears adequate. We will verify the adequacy of your corrective action during a future inspection.

5) Failure to base the finished device sampling plan on a valid statistical rationale. [21 CFR 820.250(b)]

Specifically, for the seventeen device history records reviewed by the FDA Investigator, only two had the sample size recorded. For these two device history records, lot [redacted] had a sample size of 12 of 144 cases and lot#[redacted] had a sample size of 18 of 144 cases. This sampling is not based on a statistical rationale.

Additionally, for the other fifteen device history records reviewed, no sample size was documented.

We have reviewed your response and have concluded that is inadequate because it does not address your rationale for the sample plans [redacted] that you have chosen for incoming and finished device testing. Additionally, your In-Process Inspection procedure, QAP019, does not address the sample size or how samples will be pulled for in-process subassemblies that are partially released to finished production.

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

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

Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, 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 all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt action to correct the violations and to bring your products into compliance.

Sincerely,

/S/

Carol A. Heppe
District Director
Cincinnati District
 

Cc: Larry D. Potts
President
Olsen Medical
3001 W. Kentucky Street
Louisville, KY 40211-1505

Cc: Delos R. Thacker
President
Kentucky Packaging Service, LP
1101 W. Market Street
Louisville, KY 40201