FDA WARNING_LETTER - Shanwei Honghui Daily Appliance Co., Ltd. - August 03, 2017

The FDA inspected Shanwei Honghui Daily Appliance Co., Ltd. from July 31 to August 3, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. The firm's August 23, 2017, response was deemed inadequate, lacking detail and a retrospective review of distributed products.

Key violations include: 1. **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** Filling machines were filthy, surrounded by cardboard and dirty rags, and the (b)(4) system had not been sanitized in over 10 years. 2. **Failure to Follow Written Procedures (21 CFR 211.100(b)):** The firm did not adhere to SOP HH/QB-03 for critical production steps, including raw material control, microbiological testing, equipment cleaning, documentation, in-process testing, and product release. 3. **Inadequate Laboratory Testing (21 CFR 211.165(a) and (b)):** No test records supported the release of drug products for the U.S. market. Microbiology and pH tests were not performed, and active ingredient concentrations were not determined. Contract lab reports were not provided. 4. **Failure to Ensure Component Identity (21 CFR 211.84(d)(1)