# FDA WARNING_LETTER - Lynn Medical Instrument Company - February 21, 2008

Source: https://www.keypedia.com/records/warning_letter/lynn-medical-instrument-company/c17bfd8a-0e59-4475-956c-b4a4b52ea00e

> FDA WARNING_LETTER for Lynn Medical Instrument Company on February 21, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lynn Medical Instrument Company
- Inspection Date: 2008-02-21
- Product Type: Devices
- Office Name: Detroit District Office
- Summary: On February 6-21, 2008, an FDA inspection of Lynn Medical Instrument Company in Wixom, Michigan, identified that their Accusensor Carbocone ECG Electrodes are adulterated under section 501(h) of the Federal Food, Drug and Cosmetic Act. The firm, a specification developer for these devices, failed to conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include:
1.  Failure to establish procedures for corrective and preventive actions (CAPA) (21 C.F.R. 820.100(a)).
2.  Failure to maintain complete procedures for receiving, reviewing, and evaluating complaints, including timely processing, documenting oral complaints, and determining MDR reportability (21 C.F.R. 820.198(a)). No complaints were reported since November 2005.
3.  Failure to establish procedures for preparing and submitting Medical Device Reports (MDR) (21 C.F.R. 803.17, 820.198(a)(3)).
4.  Failure to establish procedures for acceptance activities of incoming product, specifically for the Accusensor Carbocone ECG electrode (21 C.F.R. 82

## Related Officers

- [Ms.](https://www.keypedia.com/people/joanne-m-givens/7d6d17bd-5f41-4cdf-8f88-488b560f73f8)

Company: https://www.keypedia.com/companies/lynn-medical-instrument-company/2f8489d1-68fd-4e8e-aca3-2d25cca00ed8

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03