Letter serves as warning for refusing FDA inspections

The US Food and Drug Administration (FDA) has published a letter warning a Chinese company about the potential impact of its refusal to undergo an inspection of its drug product testing facility.

The agency wrote to Shanghai Institute of Pharmaceutical Industry, which is listed as a contract testing laboratory providing active pharmaceutical ingredient characterization and/or identification testing to support multiple abbreviated new drug applications, on August 29.

In the letter, the FDA raises the company’s failure to accept a planned surveillance and pre-approval inspection of its premises at the end of last year. Under the Federal Food, Drug and Cosmetic Act, such a refusal leads to a firm’s drugs being deemed adulterated.