Chinese API Maker Hit with FDA-483

FDA has posted a six-item Form FDA-483 from a 9/2023 inspection at Sichuan Deebio Pharmaceutical Co. in Guanghan, Sichuan, China, documenting significant GMP deficiencies with the firm’s active pharmaceutical ingredient manufacturing.

For example, the form took exception to Sichuan’s laboratory records not being completed contemporaneously and that they did not include complete data derived from all tests to assure compliance with specifications/standards. It also found that the firm’s quality control unit lacked responsibility to approve all procedures, specifications and test methods.

Additionally, the inspection cited Sichuan for failing to have adequate written procedures for production and process controls, written records related to investigations into unexplained discrepancies, cleaning and maintenance of equipment, and control procedures that “validate the distribution processes that may be responsible for causing variability in the characteristic of the drug substance.”