Delaying, Denying, Limiting, Refusing Inspection: Chinese Mfr Tianjin Darentag Issued FDA Warning letter

Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March 2024. During the inspection FDA observed significant GMP violations at the facility (FEI 3006283468). Manufacturing – Filling equipment were observed to be dirty and, in a state, if disrepair with residues, missing screws, missing bowl cover, broken panel. The equipment was held together by degraded and cracked bands. Investigators were not allowed to take photograph of the equipment. When FDA investigators requested for process batch records, process validation reports and equipment qualification records, they were were provided with records redacting critical information like net weights, critical process parameters, equipment parameters. The top management refused information and provided redacted copies in the guise of protecting the information. When corrective and preventive action (CAPA) reports from years 2016-2024 were requested, only records pertaining to year 2024 were provided. The investigators were also denied access to the manufacturing room. The inspectors also found lapses in laboratory control with no forced degradation studies performed and the analytical methods not stability indicating.  

As per the section 704(a) of the FD&C Act (Federal Food, Drugs & Cosmetics Act), when FDA requests information during inspection or in lieu of inspection, the same shall be provided within reasonable time frame and reasonable limits. Refusing permission of entry or inspection, access to or copying certain specified information, refusing photography in a facility are all acts of limiting inspection and a drug or device manufactured, packed or stored in the facility is deemed to be adulterated. The FDA guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection gives an overview and defines the type of behaviours that FDA considers constitute delaying , denying, limiting or refusing inspection.  

References:

• USFDA Warning letter: Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd
• USFDA Guidance Document: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection