Chinese API site inspection prompts US FDA warning
The US Food and Drug Administration (FDA) has sent active pharmaceutical ingredient (API) maker Jilin Shulan Synthetic Pharmaceutical Co. a warning letter and imposed Import Alert 66-40.
The FDA observed a number of good manufacturing practice (GMP) violations during an inspection of Jilin Shulan Synthetic Pharmaceutical Co.’s facility in Jilin Province, China, from November 7-10, 2017.
According to the letter, the firm failed to document, investigate, and resolve out-of-specification (OOS) results at the site.
Dual testing records showed OOS results, as well as results within specifications, but “you could not provide evidence to support the passing results,” said the FDA.
“You also failed to conduct investigations for the OOS results…Your quality department acknowledged this practice during the inspection,” the agency added.
The FDA also flagged inadequate electronic data security during the inspection: “Our investigator found backed up electronic data was not password-protected, and it was stored in an unlocked drawer in an unlocked office.”
The investigation also found that operators had full system permissions, including the ability to modify and delete files, according to the agency.
In addition, manufacturing activities were not recorded at the time they were performed, said the US regulator: “Our investigator found numerous examples of your failure to record manufacturing operations contemporaneously with their performance.”
“For example, our investigator discovered blank batch production records that were pre-signed by your operator, partially-completed batch records, and batch records with data changes in pencil without any justification,” the agency added.
The FDA requested Jilin Shulan Synthetic Pharmaceutical Co respond to the letter before the end of last month.