Chinese API Firm Cited for cGMPs

Northeast General Pharmaceutical Factory, an active pharmaceutical ingredient (API) supplier based in China, failed to conduct stability tests at scheduled intervals and did not appropriately maintain its equipment and facilities to prevent product contamination, according to an Oct. 31 warning letter.

The factory was cited by the FDA in a 2001 warning letter for terminating stability studies at six months. The stability test citation in the most recent letter is a repeat observation, the FDA said.

The letter, posted on the agency’s website Nov. 1, also cited the company’s quality control unit for not appropriately overseeing and evaluating manufacturing and laboratory controls.

During an inspection Aug. 27–30, FDA investigators observed residue on processing equipment, paint drips running inside of vessels, unclean and damaged ceilings in production areas and rusted bolts/flaking paint above where open API transfer baskets would be placed.

The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6566c.pdf.