Fercy Personal Care Products Co., Ltd – FDA Warning Letter, Mar 6, 2012

On September 7, 2012, the FDA issued a Warning Letter to Fercy Personal Care Products Co., Ltd. following a March 5-6, 2012 inspection of their pharmaceutical manufacturing facility in China. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug product, (b)(4), adulterated.

Key violations include: 1. **Quality Control Unit Deficiencies:** The quality control unit failed to approve or reject components, materials, and finished products, and lacked written procedures for its responsibilities (21 CFR § 211.22). Raw materials were not approved, and procedures/specifications for (b)(4) were not approved. 2. **Inadequate Production and Control Procedures:** The firm lacked written procedures to ensure drug products met identity, strength, quality, and purity standards, including active ingredient formulation and second-person verification of components (21 CFR § 211.101). 3. **Lack of Release Testing:** No laboratory determination of satisfactory conformance to final specifications, including identity and strength of active ingredients (e.g., (b)(4)), was conducted prior to release for any batches distributed to the U.S. market (21 CFR § 211.165(a)). 4.