Inspections, Compliance, Enforcement, and Criminal Investigations
PIE Medical International, Inc. 27-Apr-05
Department of Health and Human Services
Public Health Service
Atlanta District Office
April 27, 2005
Roy Abell, President
PIE* V Medical International, Inc.
4809 Riverview Way
Duluth, GA 30097-2345
Dear Mr. Abell:
During an inspection of your firm on March 1-3, 2005, our investigators determined that your firm is a specifications developer for the Pulsed Irrigation Evacuation (PIE®) Bowel Prosthetic system. This product is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above stated inspection revealed that your Pulsed Irrigation Evacuation (PIE®) Bowel Prosthetic System is 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 its manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant violations include, but are not limited to, the following:
1. Failure of management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20(a). Specifically, management with executive responsibility has failed to ensure that an adequate and effective quality system has been established. There was no management oversight for employees responsible for manufacturing, finished device release, distribution, and for maintaining quality system records. (FDA-483 item #1)
2. Failure to investigate complaints involving the failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c). Specifically, your firm received twelve (12) complaints in 2002 involving possible failures associated with speculums, containments bags, and controllers. You did not have any documentation of investigations to determine the cause(s) of the failures. Two of these complaints involved malfunctions of the PIE*® controllers, three complaints involved speculums which had holes and did not inflate properly. Seven complaints involved leaking containment bags. Your firm's only action was to send product replacements. No investigations were conducted and/or documented. (FDA-483 item #3)
3 . Failure to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b). Specifically, eighteen complaints received in 2002 had no documentation in the complaint files to determine whether an investigation was necessary. (FDA-483 item #4)
4. Failure to perform software validation, as required by 21 CFR 820.30(g). Specifically, the PIE® 2001 controller unit, software version [redacted] was changed to PIE*® 2005. The change in the software allowed for adjustment in the speed of the water pump, and inverse pulsing from the A valve to the B valve when the speculum was clogged. Your firm did not have any documentation showing that the current software version was validated. (FDA-483 item #6)
5. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, your firm did not have procedures to assure that the finished device meets established specifications. Your firm did not perform finished device testing. Your firm also did not maintain acceptance records as part of the device history record, as required by 21 CFR 820.80(e). No records were maintained to show that the devices currently in distribution were manufactured according to established specifications. (FDA-483 items #9 & 10)
6. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm did not have any documentation showing audits of the contract manufacturer responsible for manufacturing the disposable PIE® Z PAK which is used with the PIE® Bowel Prosthetic System. Your firm also did not define the type and extent of control to be exercised over the product, suppliers, and contractors. (FDA-483 item #11)
The inspection also revealed that the Pulsed Irrigation Evacuation (PIE®) Bowel Prosthetic system is misbranded within the meaning of section 502(t) (2) of the Act [21 U.S.C 352 (t) (2)], in that your firm failed or refused to funish material or information required by or under section 519 respecting the device and 21 CFR Part 803 (Medical Device Reporting regulation). Your firm failed to file an adverse event report as required by 21 CFR 803.50 (a) (1). Specifically, in August of 2004 your firm was in receipt of information in which the PIE® speculum may have caused a rectal perforation and peritonitis. You did not promptly report this incident to the FDA as an MDR reportable event.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
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, no premarket submissions for class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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. We acknowledge receipt of your March 16, 2005 response letter, however your response did not include specifics about how you planned to ensure an adequate and effective quality system; as to the software validation, no documentation was provided to verify that such validation was conducted. As to incoming inspection and finished device inspections, you did not specify if your firm will establish procedures to address how these inspections will be performed and documented.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. 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 the attention of Serene N. Ackall, Compliance Officer, at the address noted in the letterhead. If you have any questions about this letter, you can contact Ms. Ackall at 404-253-1296.
Mary Woleske, Director
Atlanta District Office