FDA WARNING_LETTER - Shanghai Institute of Pharmaceutical Industry - December 04, 2018

The FDA issued Warning Letter 320-19-40 to Shanghai Institute of Pharmaceutical Industry after the firm refused a pre-announced surveillance and pre-approval inspection of its drug product testing facility, scheduled from November 29 to December 4, 2018. The firm, a contract testing laboratory providing active pharmaceutical ingredient (API) characterization and identification for abbreviated new drug applications (ANDAs), formally refused the inspection on December 4, 2018. This refusal constitutes a violation under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), which states that drugs are deemed adulterated if the owner, operator, or agent refuses an inspection. The FDA emphasized that until the facility permits inspection and confirms compliance with current good manufacturing practice (CGMP), the agency may recommend withholding approval of any new applications or supplements listing the firm as a drug manufacturer. The firm is required to respond in writing within 15 working days, detailing its corrective actions.