DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145
April 18, 2002
Ref: 2002-DAL-WL-13
WARNING LETTER
CERTIFIED MAIL
RETURNED RECEIPT REQUESTED
Mr. Albert P. Shepherd, President
A-VOX Systems, Inc.
28267 Ruffian Drive
Fair Oaks Ranch, Texas 78015-4809
Dear Mr. Shepherd:
On March 12 through 14, 2002, our FDA investigator conducted an inspectionof your device manufacturing facility located at 12001 Network Blvd., BuildingF, Suite 210, San Antonio, Texas. Our investigator determined that your firmmanufactures several models of oximeters, which are used for whole blood measurementof total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, and oxygencontent, and disposable cuvettes. These products are medical devices as definedin Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
At the conclusion of the inspection, our investigator issued a list of InspectionalObservations (Form FDA-483) to you listing significant deviations from CurrentGood Manufacturing Practices (CGMP). Your devices are adulterated within themeaning of Section 501(h) of the Act in that the methods used in, or the facilitiesor controls used for their manufacturing, packing, storage, or installationare not in conformance with the CGMP requirements of the Quality System Regulation,as specified in Title 21, Code of Federal Requlation (CFR), Part 820. SignificantCGMP deviations include, but are not limited to, the following:
1. Failure to maintain device history records to demonstrate the devices aremanufactured in accordance with the device master record [21 CFR 820.184].
For example, your firm did not keep test records [Individual Device Records]as required by your procedures for the six oximeter devices cited in FDA-483item 1.
2. Failure to establish and maintain procedures to control product that doesnot conform to specified requirements [21 CFR 820.90]. For example, your firmfailed to maintain the non-conforming reports (NCR) as required by your proceduresfor the four oximeter devices cited in FDA-483 Item 5.
3. Failure to establish and maintain procedures for implementing correctiveand preventive action [21 CFR 820.100]. For example, your firm had not investigatedand documented the device failure causes or completed the corrective actionreports (CAR) for the non-conforming oximeter devices listed in FDA-483 Items1, 2, and 5 in order to identify the actions needed to prevent recurrence ofthe device failures.
4. Failure to maintain procedures to ensure all purchased or otherwise receivedproducts and services conform to specified requirements [21 CFR 820.50] seealso 820.80]. For example, your firm failed to ensure that the supplier of themain computer board (i.e., [redacted] Main Board) documented all of the requiredtest results to indicate the supplier?s quality acceptance of the [redacted]computer boards manufactured and delivered to your firm.
5. Failure to establish and maintain schedules and maintenance activities forthe adjustment, cleaning, and other maintenance of manufacturing equipment [21CFR 820.70(g)(l)]. For example, your firm does not have a maintenance documentationof maintenance activities for the [redacted] and the [redacted] [FDA-483 items3 and 4].
Your firm orally promised our investigator that it would correct FDA-483 Items1, 2, 5, and 6 and placed FDA-483 Items 3 and 4 under consideration. You havenot provided a written response confirming your promise and outlining specificsteps your firm has taken or will take to correct the above GMP deficiencies(although your firm stated its intention to respond in writing to the FDA-483within one month of the inspection, to date we have not received such a response).
This letter is not intended to be an all-inclusive list of deficiencies atyour facility. It is your responsibility to ensure adherence to each requirementof the Act and the regulations. The specific violations noted in this letterand in the FDA-483 issued at the close of the inspection may be symptomaticof serious underlying problems in your firm?s manufacturing and quality assurancesystems.
You are responsible for investigating and determining the causes of the violationsidentified by the FDA. If the causes are determined to be systems problems,you must promptly initiate permanent corrective actions.
Federal agencies are advised of the issuance of all Warning Letters about devicesso that they may take this information into account when considering the awardof contracts.
You should take prompt action to correct these violations. Failure to promptlycorrect these violations may result in regulatory action being initiated bythe Food and Drug Administration without further notice. These actions include,but are not limited to, seizure, injunction, and/or civil penalties.
Please provide this office in writing within 15 working days of receipt ofthis letter a report of the specific steps you have taken, or will take to identifyand correct any underlying systems problems necessary to assure that similarviolations will not recur. If corrective action cannot be completed within 15working days, state the reason for the delay and the time frame within whichthe corrections will be completed. Your reply should be directed to Thao Ta,Compliance Officer, at the above letterhead address.
Sincerely,
Michael A. Chappel
Dallas District Director
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