FDA warns two Chinese drug manufacturers for good practice violations

The US Food and Drug Administration (FDA) has issued warnings to two Chinese drug manufacturers for violations of good manufacturing practice (GMP), according to a post from the Regulatory Affairs Professionals Society (RAPS).

Sichuan Friendly Pharmaceutical and Foshan Jinxiong Technology were inspected by the regulatory body last year and before issuing the warning letters, the FDA had imposed import alerts on both earlier this year.

Sichuan Friendly Pharmaceutical received its warning letter citing four GMP violations that were observed during a five-day inspection of the company’s facility located in Neijiang. These violations include a failure to test residual solvent testing for an API that is distributed to the US; sharing equipment to manufacture multiple APIs including one that uses a Class II solvent; inadequate cleaning and maintenance procedures for non-dedicated cleaning equipment; and issues surrounding the quality control unit’s computer system.

Within the letter the FDA wrote: “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.”

Foshan Jinxiong Technology’s letter has been issued after a four-day inspection by the FDA of its facility located in Guangdong Province last year.

The agency have cited failures in adequately testing drugs the company produces as a contract manufacturer and verification of components sourced from other manufacturers. Products affected by this include over-the-counter drugs that are intended for use in children.

Additionally, the company was found to not ascertain and follow written test procedures for the establishment of shelf life and stability of its products and also lacked records containing complete information on the production and control of the drugs it produced.

In its letter, the FDA stated: “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 distributed product.”