FDA WARNING_LETTER - Osmed GmbH - July 28, 2011

On July 25-28, 2011, an FDA inspection of Osmed GmbH in Ilmenau, Germany, identified significant violations regarding their Osmed Hydrogel Tissue Expander. The device was deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Osmed's response to the FDA 483 was not reviewed as it was submitted late.

Key violations include: 1. Failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically for the (b)(4) process, lacking reproducibility demonstration and consistent parameters. 2. Failure to monitor and control process parameters for validated processes (21 CFR 820.75(b)), as (b)(4) lacked routine microbiological/endotoxin testing. 3. Failure to control non-conforming product (21 CFR 820.90(a)). 4. Failure to maintain adequate complaint files (21 CFR 820.198(a)), with a missing complaint file. 5. Failure to control design changes (21 CFR 820.30(i)). 6. Failure to maintain Device History Records (DHR