Inspections, Compliance, Enforcement, and Criminal Investigations
Flotec, Inc. 22-Mar-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
March 22, 2005
Mr. Brian R. Davidson
President and CEO
7625 W. New York Street
Indianapolis, IN 46214-4911
Dear Mr. Davidson:
An inspection of your medical device manufacturing facility was conducted on February 1-15, 2005 . The purpose of the inspection was to evaluate the adequacy of your activities related to the manufacturing of finished medical devices. The medical gas regulators and flowmeters manufactured by your firm are medical devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The inspection revealed that your medical devices are adulterated within the meaning of Section 501 of the Act, as explained further below.
The above-referenced 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 their manufacture, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (QS regulation), as specified in Title 21, Code of Federal Regulations (CFR), Part 820. The FORM FDA-483, List of Inspectional Observations, issued to you at the conclusion of FDA's inspection (copy enclosed) describes, among others, the following significant deviations from the QS Regulation:
1 . Failure to review, evaluate, and investigate any complaint involving the possible failure of a device to meet any of its specifications, in violation of 21 C.F.R. § 820.198(c).
For example: your firm failed to fully investigate complaint C04-137, stating instead in Section H.10 of the MDR number 1832475-2004-00002 that you are "[u]nable to evaluate and test for Alleged failure because of [redacted] refusal to return as requested by, Flotec." Your firm must resume its efforts to obtain the necessary information to review, evaluate, and investigate the possible failure of the device to meet any of its specifications.
2. Failure to maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, in violation of 21 C.F.R. § 820.198(a). Failure to review and evaluate all complaints to determine whether an investigation is necessary, and when no investigation is made, the failure to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, in violation of 21 C.F.R. § 820.198(b).
For example: your firm failed to fully investigate complaint C04-137 and to properly complete the Complaint Record Form - QSP 8.2-2 as required by 21 C.F.R. §§ 820.198(a) and (b). The incomplete complaint form was marked "VOID" without a date or name of the responsible individual who made that decision. See FDA-483 observation #2.
For example: your firm failed to document the complete details of customer complaints as required by 21 C.F.R. § 820.198(a). See FDA- 483 observation 5.
3 . Failure to comply with the Management Review requirements, in violation of 21 CFR § 820.20(c).
For example: your procedure QSP-5.6-1 calls for management review of customer feedback, however, you have not included complaints in the body of material for these reviews. See FDA-483 observation 13.
4. Failure to maintain complete Device Master Records (DMR), in violation of 21 CFR § 820.181. See FDA-483 observation 7.
This letter is not intended to be an all inclusive review of your firm's compliance status. It is your responsibility to assure adherence to each requirement of the regulations. Other Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, pending 510(k) or PMA applications and export approval requests may not be approved until the violations are corrected.
You should take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice, including, but not limited to, seizure, injunction, and/or civil money penalties.
Please notify this office in writing, within fifteen (15) working days of your receipt of this letter, as to the specific steps you have taken to correct these violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If correction actions cannot be completed within 15 working days, please state the reason for the delay and the time frame within which the corrections will be implemented.
Your reply should be directed to Melvin O. Robinson, Compliance Officer at the above address.
Joann M. Givens