EMG Manufacturing Co., Ltd. – FDA Warning Letter, Jun 14, 2012

On June 11-14, 2012, an FDA inspection of EMG Manufacturing Co., Ltd. in Dongguan City, China, revealed that their Class II Compressor Nebulizers and Class II AC/DC Suction Units were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820). The firm's July 6, 2012, response to the FDA 483 was deemed inadequate.

Key violations included: 1. **Design Validation (21 CFR 820.30(g)):** Failure to validate device design for the NBX02 Series Compressor Nebulizer-Model #NBA02-A70 and inadequate design control procedures. 2. **In-process Acceptance Procedures (21 CFR 820.80(c)):** Allowing products to pass despite failing in-process tests and lacking adequate acceptance procedures. 3. **Environmental Control (21 CFR 820.70(c)):** Inadequate control of environmental conditions (e.g., open windows, circulating dust) affecting product quality. 4. **Sampling Methods (21 CFR 820.250(b)):** Use of sampling plans not based on valid statistical rationale. 5. **Complaint Handling (21 CFR