Inspections, Compliance, Enforcement, and Criminal Investigations
Bunnel, Inc 29-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Denver District Office
Building 20 ? Denver Federal Center
Denver, Colorado 80225-0087
October 29, 2001
RETURN RECEIPT REOUESTED
Ref. # - DEN-02-04
Mr. James Bert Bunnell
Chief Executive Officer
436 Lawndale Drive
Salt Lake City, Utah 84115
Dear Mr. Bunnell:
An inspection of your firm located at 436 Lawndale Drive, Utah was conducted between September 10-14, 2001, by Investigator Nicholas R. Nance. This inspection determined that your firm manufactures high frequency jet ventilators and accessories for neonatal use. These ventilators are devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act).
The above stated inspection revealed that these devices are adulterated within the meaning of Section 501 (h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System/Good Manufacturing Practice (QS/GMP) for Medical Devices Regulation, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820. The deviations are as follows:
Failure to conduct management reviews to determine the suitability and effectiveness of the quality system, as required by 21 CFR 820.20(c). For example, not all sources of quality data are reviewed, tracked or trended by management, such as sub-assembly reject data and finished product testing failures. Management review meeting procedures do not stipulate the sources of quality data to be reviewed, how data is to be analyzed or how the results of reviews will be documented.
Failure to conduct quality audits to assure that the quality system is in compliance and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, audits scheduled to be performed have not been conducted. Audit schedules do not require all areas to be audited, for example corrective and preventive actions, management, complaint files and validation records. Procedures do not require re-audits of areas found to be deficient.
Failure to establish and maintain procedures for corrective and preventive actions (CAPA) to include requirements to assure corrective actions are implemented and changes in methods and procedures to correct and prevent identified quality problems ark recorded, as required by 21 CFR 820. 100(a)(5). For example, your CAPA procedure does not provide specific guidelines/timeframes in which corrective action reports (CARS) are to be closed. Several CARS were found to be open over a year after they were initiated.
Failure to establish adequate CAPA procedures in that your procedures lack verification or validation to ensure that such action is effective and does not aversely affect the finished device, as required by 21 CFR 820. 100(a)(4). For example, there is no evidence that non-conformance and corrective action reports are evaluated for safety and efficacy.
Failure to establish CAPA procedures that assure all relevant information on identified quality problems, as well as corrective and preventive actions, are submitted for management review, as required by 21 CFR 820. 100(a)(7). For example, there is no evidence that actions taken to address defective ventilator alarm printed circuit boards have been reviewed and approved by the [redacted] or by [redacted].
Failure to validate processes that cannot be fully verified by subsequent-inspection and test, as required by 21 CFR 820.75(a). For example, the complaint handling software program, ultrasonic sealing procedure, leak testing procedure, and injection molding procedure have not been validated. Also, changes made to the ventilator burn-in procedure/process have not been validated.
Failure to control nonconforming product to assure that it is identified, evaluated, segregated disposed of according to procedures, as required by 21 CFR 820.90(a). For example, review of in-process production reject records revealed instances of missing data, such as status and disposition of defective products.
Failure to establish sampling plans based on a-valid statistical rationale and to ensure that sampling methods are adequate for their intended use, as required by 21 CFR 820.250(b). Also, there is no evidence that sampling methods are reviewed when changes are made. For example, our inspection revealed that your firm uses [redacted]. There is no evidence of the statistical rationale for this decision. Also, there have been modifications made to allow for accepting lots even if the reject number has been reached. There is no evidence that these modifications have been justified.
Failure to document component acceptance activities in order to verify conformance with specified requirements, as required by 21 CFR 820.80(b).For example, incoming inspection records were found to be missing sampling plans used at the time of the inspection, as required by your firm?s procedures. Other discrepancies noted on inspection records included incorrect lot sampling sizes, missing temperature recordings or the acceptance/rejection status of the lot.
The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence with each requirement of the regulations, as well as other requirements of the .Act. Continued distribution of violative devices may result in regulatory action without further notice. These actions include, but are not limited to seizure, injunction, and/or civil penalties.
Federal agencies are advised of the issuance of all warning letters regarding medical devices so that they may take this information into account when considering the award of contracts.
You should notify this office in writing within 15 working days of receipt of this letter, of any 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 connective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the correction will be completed.
Your reply should be sent to the Food and Drug Administration, Denver District Office, P.O. Box 25087, Denver, CO 80225-008, Attention: Regina A, Barren, Compliance Officer. If you have any further questions, please feel free to contact Ms. Barren at (303) 236-3043.Sincerely,
Thomas A. Allison