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

Source: https://www.keypedia.com/records/warning_letter/alpha-medical-instruments-llc/47d944b0-d6e6-4d28-811e-83ee35f608fc

> FDA WARNING_LETTER for Alpha Medical Instruments, LLC on August 14, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Alpha Medical Instruments, LLC
- Inspection Date: 2014-08-14
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2013-01-11](https://www.keypedia.com/records/warning_letter/alpha-medical-instruments-llc/75576c1f-1643-45f6-885e-ae70358542f5)

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Harlan Loui](https://www.keypedia.com/people/harlan-loui/8a3550a1-da44-49cd-b5a9-bfb62663013a)

Company: https://www.keypedia.com/companies/alpha-medical-instruments-llc/8bd95223-b406-4336-a733-cd8af2d87241

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b