The U.S. FDA sent a warning letter to Unimark Remedies, following the inspection of its API manufacturing facility in Bavla, India, noting data integrity issues and GMP violations.
The letter, which referenced a March 2014 inspection, noted data integrity issues including: failure to document production and analytical testing activities; failure to prevent unauthorized access or changes to data; failure to maintain complete data derived from all testing and to ensure compliance with established standards.
In addition, the FDA investigator found a wild lizard, what appeared to be a bird’s nest near the ceiling, and bird feces in the general raw material warehouse.
According to RAPS, Unimark Remedies makes APIs used for the antibiotics cephalosporin and carbapenem.
Read the FDA Warning Letter