FDA WARNING_LETTER - Alpha Medical Instruments, LLC - August 14, 2014

On October 7, 2014, the FDA issued a Warning Letter to Alpha Medical Instruments, LLC, following an inspection from August 5-14, 2014, which found their angiographic balloon catheters to be adulterated. The firm failed to conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish CAPA procedures (21 CFR 820.100(a))**: CAPA 104 (balloon extension air leaks) was closed without effectiveness checks, and subsequent non-conformities (NCR #58, #59) and complaints (YR-14-8, YR-14-10) regarding leaks were not adequately analyzed or addressed. CAPA 107 (needle protective sheaths) lacked documented effectiveness checks, and a later complaint (YR-13-8) was not linked to it. The firm's response was inadequate, lacking evidence of implemented corrective actions. 2. **Failure to establish complaint handling procedures (21 CFR 820.198(a))**: Complaint files (YR-14-11, YR-14-10, YR-14-8) were incomplete, lacking information on device use for treatment, MDR reportability, and complainant replies. The firm's response was inadequate