A number of deviations from current good manufacturing practice (cGMP) were discovered by the US Food and Drug Administration (FDA) during an inspection in September last year at the two facilities located in Xinxiang City, Henan.
This resulted in both facilities being placed on import alert 66-40 in April, and Xinxiang Tuoxin receiving a warning letter, details of which the FDA released this week.
The Agency said the API maker failed to properly maintain equipment, and repair and keep clean buildings used in the manufacture of pharmaceutical ingredients.
“Our investigator observed non-dedicated drug manufacturing equipment in a state of disrepair,” the FDA wrote in the letter dated August 19. “For example, product contact surfaces of your (b)(4) and reactors contained significant (b)(4), product buildup, and chipped paint.”
In another example, the firm was found to have used open equipment for the manufacture of API:
“Our investigator observed chipped paint on the ceiling directly above open (b)(4), which could have fallen into your open equipment and contaminated your API.
“Our investigator also observed gaps around windows and doors, and holes in ceilings directly above open (b)(4). Flying insects that were observed in clean rooms and on product transfer (b)(4) may have entered through these gaps and holes.”
According to its website, Xinxiang Tuoxin Biochemical makes 25 products for drug makers, including eight antibiotic APIs, and adenine sulfate and uracil as intermediates.