Reine Lifescience Cited for Adulterated APIs

The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India.

The investigator found that the firm had no documentation of validation or verification of its analytical methods. In addition, the results of analytical data found in a product development folder differed greatly from the firm’s recorded test results.

The agency asked the company to improve and document its method validation and verification studies involved in product release.