FDA WARNING_LETTER - Ambco Electronics, A California Corp - July 27, 2014

On September 26, 2014, the FDA issued a Warning Letter to Ambco Electronics following an inspection from July 8-27, 2014, which found their Audiometers (Models: 1000+, 650A, 650AB, 2500) to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Inadequate Documentation of CAPA Activities (21 CFR 820.100(b)):** Previous CAPA actions from 2008 regulatory inspections were marked as completed, but lacked documentation of correction. Many deficiencies, including those related to receiving inspection, component traceability, acceptance activities, and training, remained uncorrected. 2. **Failure to Establish CAPA Procedures (21 CFR 820.100(a)):** The CAPA SOP #J-001, Rev A, was not implemented, specifically regarding trending analysis of customer complaints/malfunctions (CERs). 3. **Inadequate Complaint Investigations (21 CFR 820.198(c)):** Device failures reported in CERs lacked detailed investigation, test data, and trend analysis, as required by SOP M-005,