Lax API testing lands Chinese CMO US FDA warning letter
The US Food and Drug Administration has placed Foshan Jinxiong Technology on Import Alert and issued a warning letter following an inspection at the contract manufacturing organisation’s (CMO’s) facility in Foshan City, Guangdong Province, in August last year.
According to the Agency, the firm – which makes over-the-counter (OTC) drug products for children – lacks adequate testing procedures for active pharmaceutical ingredients (APIs).
During the inspection, the FDA observed Foshan Jinxiong Technology had “released multiple lots of OTC drug product without data to support their conformance to specifications, including identity and strength.”
In addition, according to the FDA, the firm did not include a testing requirement to examine identity and strength of each lot prior to distribution: “You also did not provide active ingredient identity and strength test results of retain samples to support the quality of the drugs you have distributed to the US.”
Lax testing procedures for incoming ingredients was also flagged by the Agency: “Your firm failed to adequately test incoming components…for their identity. Instead, your firm relied on certificates of analysis (COA) from unqualified suppliers.”
The FDA ‘strongly recommends’ Foshan Jinxiong Technology employ a third-party consultant qualified to help address the current good manufacturing practice (cGMP) concerns.
