FDA WARNING_LETTER - Aptalis Pharma Us Inc - August 29, 2013

On August 21-22, 26, and 28-29, 2013, the FDA inspected Aptalis Pharma US, Inc., a specification developer of the Class II medical device "Flutter." The inspection found the device adulterated under 21 USC 351(h) because manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820).

Violations included: 1. Failure of Medical Device Reporting (MDR) procedures to require documentation of all information evaluated for reportability (21 CFR 803.17(b)(1)). 2. Failure to justify not reporting device correction/removal actions to FDA, lacking required documentation (21 CFR 806.20(b)(4)). 3. Failure to establish adequate Corrective and Preventive Action (CAPA) procedures for analysis, investigation, verification/validation, and documentation of changes (21 CFR 820.100(a)). 4. Failure to adequately document CAPA activities and results, specifically regarding complaint records (21 CFR 820.100(b)). 5. Failure to establish and maintain adequate complaint handling procedures for all complaint types, including oral complaints, and evaluation for MDR reporting (21 CFR 820.198