FDA WARNING_LETTER - Shanghai Huhui Daily Use Chemical Products Co., Ltd. - February 10, 2012

The FDA issued a Warning Letter to Shanghai Huhui Daily Use Chemical Products Co., Ltd. on November 14, 2012, following a February 6-10, 2012 inspection. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Refusal to provide component test records:** The firm refused to provide test records for active pharmaceutical ingredients (APIs) like (b)(4) and (b)(4), redacting information from specification sheets. This was deemed an unreasonable denial of access. 2. **Inadequate Quality Control Unit (QCU):** The QCU failed to adequately review batch production records, leading to discrepancies (e.g., conflicting production and cleaning times, unexplained yield differences, untraceable lot numbers). The use of opaque correction fluid on records without proper notation also raised concerns about data integrity. 3. **Failure to establish and follow adequate production and process control procedures:** The firm had not conducted process validation or equipment qualification for (b)(4) Skin Protectant Cream manufacturing and packaging processes. The QCU had not approved batch production records, and personnel were not following transferred records. 4. **Inadequate stability testing program:** The firm lacked data to support expiration dates for products like (b)(4) Skin Protectant Cream, did not have a written testing program