FDA EIR - The United Laboratories (Inner Mongolia) Co. Ltd. - December 01, 2017

An FDA inspection of The United Laboratories (Inner Mongolia) Co., Ltd. was conducted from November 27 to December 1, 2017. The inspection, focusing on Active Pharmaceutical Ingredient (API) manufacturing for human and animal use, adhered to ICH Q7 guidelines and relevant FDA Compliance Program Guidance Manuals for API and pre-approval inspections. During the inspection, a multi-point Form FDA 483, Inspectional Observations, was issued, detailing six significant deficiencies. These included a failure to properly control computer systems, resulting in lost electronic raw data, and a lack of validated methods for testing recovered solvents. The firm also demonstrated inadequate process validation for solvent recovery and failed to routinely monitor water for microbial contamination, a critical aspect of API manufacturing. Furthermore, the building structure was was deemed unsuitable, with issues like peeling ceilings and microbial growth observed in the water pool area. Finally, the company failed to conduct thorough investigations into product complaints, as evidenced by a lack of documentation regarding related batches. Management at The United Laboratories (Inner Mongolia) Co., Ltd. acknowledged the observations and committed to submitting a written response to the FDA within 15 business days.