AG Industries LLC – FDA Warning Letter, Apr 13, 2015

On March 26-April 13, 2015, an FDA inspection of AG Industries LLC in St. Louis, Missouri, revealed significant deviations from Quality System Regulations (21 CFR Part 820) for medical devices, rendering their products adulterated.

Key violations include: 1. **Complaint Handling (21 CFR 820.198(d)):** Failure to promptly review, evaluate, and investigate complaints, specifically not filing a Medical Device Report (MDR) for a serious complaint (shock to a child from a mini-nebulizer). The firm's response was deemed inadequate, lacking evidence of revised procedures or training, and demonstrating ineffective management oversight. 2. **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate equipment (four specific machines lacked approved Installation Qualifications, Operation Qualifications, and adequate Performance Qualifications) and the process of adding reground plastic material to fresh resin. The firm's response was inadequate, attributing issues to "employee oversight" and failing to address accepting failed validation data by changing specifications. 3. **Finished Device Acceptance (21 CFR 820.80(d)):** Failure to establish adequate procedures for finished device acceptance, with insufficient product quality inspections documented for medical device #AG7178 (filter) Lot (b)(4). This was a repeat observation from 2010