FDA WARNING_LETTER - Mapa Gmbh - September 19, 2013

On September 16-19, 2013, an FDA inspection of MAPA GmbH in Zeven, Germany, revealed that their breast pumps and latex condoms are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's response dated October 2, 2013, was deemed inadequate.

Violations include: 1. Failure to monitor and control process parameters for validated processes (21 CFR 820.75(b)), specifically regarding in-process latex condom testing. 2. Failure to revalidate processes after changes or deviations (21 CFR 820.75(c)), such as new parameters for latex condom dipping and sealing machines. 3. Failure to validate computer software for intended use (21 CFR 820.70(i)), specifically the (b)(4) software for condom production control tests. 4. Inadequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), lacking requirements for implementing changes, verification/validation, effectiveness checks, statistical methodology, and information dissemination. 5. Failure to maintain complaint files and adequate complaint handling procedures (21 CFR 820.198(a)),