Chinese API maker Jilin Shulan Synthetic Pharma was hit with a warning letter by the FDA, which cited numerous quality-control and data-integrity issues.
The letter, which was posted on the regulatory agency’s website, came in reaction to the company’s response to an FDA inspection conducted at Synthetic Pharma’s facility in Shulan City, China, last November.
According to the company’s website, Synthetic is one of the largest producers of caffeine. The plant also produces aminophylline used in muscle relaxants and 8-chloro theophylline used in motion-sickness drugs.
The FDA said inspectors found that the company failed to “ensure that manufacturing process deviations are documented, and any critical process deviations are investigated, and resolved.”
Inspectors also uncovered two sets of laboratory records and said the company didn’t investigate out-of-specification results in its laboratories.
The company was also cited for inadequate security measures for its computer systems and failure to record activities when they are performed.
“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 FDA wrote.
As a result of the inspection, the agency placed Synthetic on its import alert list in early March.