Ingredient manufacturer Centaur gets FDA warning over records, substandard cleaning
Active pharmaceutical ingredient maker Centaur Pharmaceuticals received a warning letter from the FDA in early June over several issues at its manufacturing site in the city of Thane, India, near Mumbai.
The agency inspected the site in November of last year. The FDA found that the site’s quality unit didn’t have the proper control over electronic and paper records. Specifically, the FDA found different documents that were pre-printed and blank in laboratory drawers and cabinets that had unrestricted access. Documents were also shredded without review.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.