FDA WARNING_LETTER - InnoMed Technologies, Inc. and RespCare, Inc. - September 21, 2007

On February 21, 2008, the FDA issued a Warning Letter to InnoMed Technologies, Inc., and RespCare, Inc., following an inspection from September 19-21, 2007. The firms, operating under the same management and registration, are specification developers and importers of Class II CPAP interface devices. The inspection found their devices adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish and maintain supplier requirements (21 CFR 820.50(a))**: The "Self Assessment Questionnaire" lacked process validation requirements for contract manufacturers and did not require evidence to substantiate "yes/no" answers, failing to ensure supplier conformity. 2. **Inadequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)(4))**: Procedures did not require verification/validation of CAPA effectiveness. For example, RespCare failed to verify a 2006 CAPA for misassembled valves, leading to recurring complaints. 3. **Failure to perform and document design validation (21 CFR 820.30(g))**: InnoMed