Taizhou Jingshang Cosmetics Technology Co., Ltd. – FDA Warning Letter, Nov 21, 2024

On April 2, 2025, the FDA issued a Warning Letter to Taizhou Jingshang Cosmetics Technology Co., Ltd. following an inspection from November 18-21, 2024. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm failed to respond to the FDA 483.

Key violations include: 1. **Failure to test components:** The firm did not conduct identity testing for each drug product component, including incoming (b)(4) (an active pharmaceutical ingredient) and other high-risk components for (b)(4) contamination, and failed to validate supplier test analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)). 2. **Incomplete laboratory records:** Laboratory records lacked complete data, with electronic data deleted and paper records illegible and untraceable (21 CFR 211.194(a)). 3. **Inadequate Quality Control Unit:** The Quality Control Unit failed to ensure CGMP compliance and product specifications were met (21 CFR 211.22).

The firm committed to ceasing drug production. If manufacturing resumes, they must notify the FDA and engage a qualified