FDA Warns Two Drugmakers Over GMP Issues
The US Food and Drug Administration (FDA) has warned two Chinese drugmakers, Sichuan Friendly Pharmaceutical and Foshan Jinxiong Technology for good manufacturing practice (GMP) violations stemming from inspections last year.
Prior to issuing the warning letters, FDA placed both companies on import alert earlier this year.
Sichuan Friendly Pharmaceutical
In its warning letter to Sichuan Friendly, FDA cites the company for four GMP violations observed during a five-day inspection of the company's Neijiang, Sichuan facility in October 2017.
According to FDA, the company failed to test residual solvent testing for one of its active pharmaceutical ingredients (API) that was distributed to the US. FDA notes that the company manufactured the API on shared equipment used to manufacture other APIs, including one that uses a Class II solvent. Class II solvents require greater controls in manufacturing due to their toxicity and potential to cause adverse events in patients.
FDA also says Sichuan Friendly failed to adequately validate its cleaning and maintenance procedures for non-dedicated cleaning equipment, as it only validated cleaning processes for certain equipment.
Specifically, FDA says the API the company used to test its cleaning procedures was only used on a portion of its manufacturing equipment and did not perform cleaning validation on the remaining equipment.
FDA also took issue with the company's controls over its quality control unit's computer systems.
"You used a non-validated Excel spreadsheet to calculate assay results for [redacted] USP for product release and stability testing. Our investigator found that this spreadsheet lacked password protection and contained unlocked calculation formulas which were incorrect," FDA writes.
FDA says the company's quality control manager acknowledged that the formula was incorrect and that certificates of analysis based on data from that spreadsheet were inaccurate.
Foshan Jinxiong Technology
Following a four-day inspection of Foshan Jinxiong's Guangdong Province facility in August 2017, FDA is citing the company for failing to adequately test drugs it produces as a contract manufacturer and for not verifying the identify of components sourced from other manufacturers.
According to FDA, Foshan Jinxiong released multiple lots of over-the-counter drugs intended for children "without data to support their conformance to specifications, including identity and strength."
FDA also says the company failed to establish and follow written test procedures to establish shelf life and stability for its products.
Additionally, FDA says the company lacked records containing complete information on the production and control of the drugs it produced.
"You failed to have specific identification for each lot of component, and production equipment, used in manufacturing. You also failed to have unique lot or control numbers for the distibuted product," FDA writes.
Warning Letters: Sichuan Friendly, Foshan Jinxiong