# FDA WARNING_LETTER - Chromsystems Instruments & Chemicals GmbH - March 20, 2014

Source: https://www.keypedia.com/records/warning_letter/chromsystems-instruments-chemicals-gmbh/cea70007-31d6-44f7-b220-4fb336795544

> FDA WARNING_LETTER for Chromsystems Instruments & Chemicals GmbH on March 20, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Chromsystems Instruments & Chemicals GmbH
- Inspection Date: 2014-03-20
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On August 8, 2014, the FDA issued a Warning Letter to Chromsystems Instruments and Chemicals GmbH following an inspection from March 17-20, 2014, in Grafelfing, Germany. The inspection found that the firm's immunoassay and reagent-based products, classified as medical devices, were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This was due to non-conformity with current good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to maintain investigation records for complaints (21 CFR 820.198(e))**: At least 3 of 13 complaint forms lacked investigation details, and there was no evidence of review for similar issues across complaints. The firm's response was inadequate as it did not provide evidence of a retrospective review of all complaints or documented complete investigations for specific complaints (CS-1404, CS-1596, CS-1609).
2.  **Failure to establish and maintain procedures for incoming product acceptance (21 CFR 820.80(b))**: The firm's procedure did not require checking temperatures of incoming temperature-sensitive products (e.g., blood, plasma, serum) or verifying that chemical raw materials complied with specifications on the Certificate

## Related Officers

- [Director](https://www.keypedia.com/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)

Company: https://www.keypedia.com/companies/chromsystems-instruments-chemicals-gmbh/1205b480-038d-4b30-b2e3-822de58ec2fb

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7