FDA hits Chinese API maker Jilin Shulan Synthetic Pharma with warning letter

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 Jilin’s facility in Shulan City, China, last November.According to the company’s website, Jilin 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.