# FDA WARNING_LETTER - EMG Manufacturing Co., Ltd. - June 14, 2012

Source: https://www.keypedia.com/records/warning_letter/emg-manufacturing-co-ltd/021584be-af4e-4a1f-a36e-96daa18b0de9

> FDA WARNING_LETTER for EMG Manufacturing Co., Ltd. on June 14, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: EMG Manufacturing Co., Ltd.
- Inspection Date: 2012-06-14
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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