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

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