The FDA’s Division of Pharmaceutical Quality Operations hit repackager Loxha with a warning letter for lacking stability data and other GMP failures.
During an inspection of its Worcester, Mass. facility, the agency found that the company set expiration dates for repackaged drug products without stability data to back them up.
For example, it repackaged four lots of atovaquone oral suspension, an antifungal and antiparasite, and assigned them a 12-month expiration date without supporting stability data. The firm recalled the batches because of the error, but it failed to provide data justifying the six-month expiration dates it later assigned, the agency said.
Loxha was also cited for its complaint investigations, noting the investigations were “not thorough, lack a description of the investigation, and do not include evidence supporting the conclusions.”