Inspections, Compliance, Enforcement, and Criminal Investigations
Parker, Norva R 07-Sep-05
Department of Health and Human Services
Public Health Service
September 7, 2005
RETURNED RECEIPT REQUESTED
Ms. Norva R. Parker
220 N . Anthony Street
Muskogee, OK 74403
Dear Mrs. Parker:
During an inspection of your establishment located at the above-referenced address, on June 30, 2005 through July 19, 2005, our investigator determined that you are a contract manufacturer that manufactures the Stim Flex Model 400 and Model 400A, a transcutaneous electrical nerve stimulator (TENS) for pain relief. This product is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). 21 U.S.C. 321(h).
The above-stated inspection revealed that your devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. § 351(h)) because the methods used in, or the facilities or controls used for the manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
At the close of the inspection, you were issued a List of Inspectional Observations, Form FDA-483, which identified a number of significant QS Regulation violations including, but not limited to, those described below.
Quality System Regulation
1. Failure to establish and implement 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), and failure to maintain acceptance records, as required by 21 CFR 820.80(e) [FDA-483 Items 2, 3, 4]. For example, your firm has no written procedures for final acceptance testing of the Stim Flex Model 400A and has not documented the final acceptance test results for the Stim Flex 400 and 400A devices.
2. Failure to establish and maintain procedures for acceptance or rejection of incoming product, including documentation of the results of acceptance or rejection, as required by 21 CFR 820.80(b) [FDA-483 Items 2, 3, 5]. For example, your firm has no written procedures for the inspection, testing or verification of incoming components (e.g. printed circuit boards, resistors, transistors, etc.) that are received from the vendors or the specification developer and has not documented receiving acceptance results.
3. Failure to establish and maintain documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production, as required by 21 CFR 820.70(a)(1) [FDA-483 Items 6, 7]. For example, your firm has no written assembly procedures for (a) the case enclosure of the Stim Flex 400 device, and (b) the Stim Flex 400A device which has incorporated several changes from the Stim Flex 400 device including a [redacted] a change in the placement [redacted] and a shift in the location of the [redacted].
4. Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184 [FDA-483 Item 8]. For example, your firm does not maintain any device history records for the Stim Flex 400 and 400A devices, including the dates and quantity of manufacture, the quantity released to the specification developer, and the results of acceptance activities.
5. Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, including validation or verification of changes in accordance with 21 CFR 820.75, and approval of changes in accordance with 21 CFR 820.40, as required by 21 CFR 820.70(b) [FDA-483 Items 1, 9, 10]. For example, the specification developer has made a number of changes to the Stim Flex 400 device to create the Stim Flex 400A device. Changes included a [redacted] a change in the placement [redacted] and a shift in the location of the [redacted] and its associated [redacted].Your firm has no written procedures to ensure that (a) changes are reviewed, documented, and approved by your firm and the specification developer; (b) changes are validated or verified to determine if there is any adverse effect to the device; and (c) device assembly procedures and final device acceptance testing procedures are reviewed to determine whether or not they need to be revised to accommodate the changes.
6. Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and for documenting specific information in distribution records, as required by 21 CFR 820.160 [FDA-483 Item 11]. For example, your firm's distribution records do not document the name and address of the initial consignee (e.g. specification developer) and the date that the devices are delivered.
Responding to This Letter
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 the regulations. The specific violations noted in this letter and in the Form FDA-483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
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 applications for premarket approval to which the Quality System regulation deficiencies are reasonably related will be 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 violations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken, or will take to identify and correct the noted violations, including (1) the timeframes within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW140, 4040 N Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
Michaell A. Chappell
Dallas District Director