Inspections, Compliance, Enforcement, and Criminal Investigations
American Thermal Instrument Inc. 14-Jun-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
June 14, 2005
VIA FEDERAL EXPRESS
Marvin L. Kidd, Owner
American Thermal Instrument Inc .
9 Huffman Avenue
Dayton, OH 45403-1913
Dear Mr. Kidd:
An inspection of your medical device manufacturing firm located in Dayton, OH conducted by our investigator on April 19-21 and 27, 2005, revealed that your firm manufactures liquid crystal forehead thermometers . These are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321(h)] . They are Class 11 devices as defined in Title 21, Code of Federal Regulations (CFR), section 880.2200.
Your devices are 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 manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), as specified in 21 CFR Part 820.
The deviations from the QSR include, but are not limited to, the following:
1. Failure to validate a process whose results cannot be verified by subsequent inspection and test. [21 CFR 820.75(a)] Specifically, the process validation for coating, drying, and cutting of liquid crystals on the Mylar material, which forms the final liquid crystal thermometers, has not been performed . This part of the process is not 100% verified, and the final process testing only pulls three samples.
2. Failure to develop production processes to ensure that the liquid crystal thermometers conform to their specifications. [21 CFR 820.70(a)] Specifically, your firm has not established acceptable tolerances for the formulas used to produce the batches of liquid crystals that are components of the finished device. Additionally, when developing your master formula for the thermometers, only one batch was tested.
3. Failure to establish sampling plans which are based on statistical rationales and are adequate for their intended uses. [21 CFR 820.250(b)] For example, only [redacted] thermometers were finished device tested for production run #3090, which consists of [redacted] liquid crystal thermometers. Your sampling plan of testing three thermometers is not based on a statistical rationale, and your firm has no procedure addressing where the samples should be taken.
4. Failure to document the results of certain acceptance activities. [21 CFR 820.80(e)(3)] Specifically, 5 of the [redacted] Crystal Production Sheets (Form QF04-02) reviewed by the FDA investigator, did not have the final temperature readings documented for the production of liquid crystals, which are a major component in the forehead thermometers.
5 . Failure to review the associated data and documentation and authorize the release of the liquid crystal forehead thermometers by the signature of a designated individual prior to their distribution. [21 CFR 820.80(d)(2) and (3)]
6. Failure to conduct quality audits to assure that the quality system is in compliance with established quality system requirements. [21 CFR 820.22] Specifically, your "Internal Audit Procedure" only addresses ISO requirements and does not include instructions to determine if the quality management system meets the requirements of the Quality System Regulation (21 CFR Part 820).
7. Failure to establish quality system procedures . [21 CFR 820.20(e)] Specifically, all quality procedures were written to address ISO requirements and do not adopt or address the Quality System Regulation (21 CFR Part 820).
8. Failure to establish training procedures and to adequately train personnel to perform their assigned responsibilities . [21 CFR 820.25(b)] Specifically, no quality or manufacturing employees have been trained on the Quality System Regulation.
The inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act [21 U.S .C. 352(t)(2)], in that your firm failed to develop, maintain, and implement written Medical Device Reporting procedures, as required by 21 CFR 803.17.
These are serious violations of the law. You should take prompt action to correct them. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice . Possible actions include, but are not limited to, seizure, injunction, and/or civil penalties.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As owner of American Thermal Instruments Inc., it is your responsibility to assure adherence to each requirement of the Act and regulations. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective actions.
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 these deficiencies. In addition, please submit any additional documentation to show the corrections initiated in conformance with the requirements of the Quality System Regulation. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
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, no requests for Certifications to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Your written response to this Warning Letter should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, extension 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe