Ningbo BST Clean and Care Products Co., Ltd – FDA Warning Letter, Jun 14, 2019

The FDA issued a Warning Letter to Ningbo BST Clean and Care Products Co., Ltd. on November 27, 2019, following an inspection from June 10-14, 2019. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test drug products:** The firm released OTC drug products without adequately testing each batch for active ingredient identity and strength. Records showed the last test for active ingredient content was in 2011. 2. **Inadequate Quality Control Unit:** The firm lacked an adequate Quality Unit (QU), evidenced by missing written procedures for numerous functions (e.g., batch release, change control, complaint handling, recalls, annual product review, equipment qualification, deviations, cleaning), failure to ensure issuance of production batch records, and absence of a stability program. 3. **Poor facility maintenance:** The facility had dirty and cracked floors/walls, black mold-like stains in the warehouse, and a pest infestation (bird nest, droppings) in the QC laboratory. 4. **Lack of equipment cleaning procedures:** The firm had no established equipment cleaning program, no records of cleaning, and no knowledge of cleaning validation. Procedures for routine equipment calibration, inspection, maintenance, and storage were also absent.

The FDA deemed the company's initial response inadequate