Inspections, Compliance, Enforcement, and Criminal Investigations
Lynn Medical Instrument Company 14-Apr-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
April 14, 2008
Brian G. Fagnani
President and Owner
Lynn Medical Instrument Company
50120 Pontiac Trail
Wixom, MI 48393
Dear Mr. Fagnani:
During an inspection of your firm located in Wixom, Michigan on February 6-21, 2008, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer (specification developer) for the Accusensor Carbocone ECG Electrodes. Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed these 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, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Your firm failed to establish procedures for implementing corrective and preventive actions (CAPA) as required by 21 C.F.R. 820.100(a). Specifically, there are no CAPA procedures describing the following: analyzing processes, work operations, quality audits, service records, and returns; investigating the cause of nonconformities, identifying the actions needed to correct and prevent recurrences; verifying or validating corrective actions; implementing changes, and ensuring the information related to the non-conformities is disseminated to the correct individuals.
2. Your firm failed to maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit as required by 21 C.F.R. 820.198(a). Specifically, your Customer Compliance procedure is incomplete in that it does not provide instructions for receiving, reviewing and evaluating complaints. In addition, your procedure is incomplete in that it does not ensure that: (a) all complaints are processed in a timely manner; (b) oral complaints are documented; and (c) complaints are evaluated to determine whether the complaint represents an event required to be reported to the FDA as a medical device report (MDR), as there were no complaints reported since November 2005.
3. Your firm failed to establish a procedure for preparation and submission of Medical Device Reports (MDR) as required by 21 C.F.R. 803.17 concerning any complaints found to be reportable, as required by 21 C.F.R. 820.198(a)(3).
4. Your firm failed to establish procedures for acceptance activities of incoming product as required by 21 C.F.R. 820.80(b). Specifically, there are no incoming acceptance procedures for the Accusensor Carbocone ECG electrode.
5. Your firm failed to maintain purchasing data such as documents including, where possible, an agreement from the supplier to notify you of any changes in the product or service as required by 21 C.F.R. 820.50(b).
6. Your firm failed to establish effective procedures for or conduct quality audits, as required by 21 C.F.R. 820.22.
7. Your firm failed to establish procedures for and conduct training of your employees, as required by 21 C.F.R. 820.25. Specifically, no formal training relating to the Quality System regulations has been provided.
8. Management with executive responsibility has failed to ensure that an adequate quality system has been fully implemented and maintained at all levels of your organization, as required by 21 C.F.R. 820.20. Your firm has no documented appointment of a management representative, as required by 21 C.F.R. 820.20(b)(3), and no procedures defining management reviews, as required by 21 C.F.R. 820.20(c). As of June 1, 2007, no management reviews had been conducted since April 2005.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter. of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Steven B . Barber, Director of Compliance, at the above address.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.
The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Joann M. Givens
Detroit District Office