FDA Warns Chinese API Maker for Heparin Operations
The FDA issued a warning letter to a Yibin, Sichuan API manufacturer for serious recordkeeping violations related to its crude heparin manufacturing operations.
An agency inspection of the Yibin Lihao Bio-technical revealed batches of crude heparin that lacked any manufacturing and testing records.
“At the start of the FDA inspection…your firm stated to the investigator that you were not manufacturing crude heparin and were only performing equipment testing,” the agency noted.
Numerous records were found scattered around the floor, desks and cabinets of the quality assurance office, including batch production records for heparin.