FDA Cites Sterility Testing, Quality at Brazilian Drugmaker

Antibioticos do Brasil (ABL), a Brazilian manufacturer of sterile active pharmaceutical ingredients (APIs) and finished dosage products, did not adequately address GMP deficiencies even though it sent three response letters and three emailed corrective action updates following the FDA’s inspection of its facility.

A warning letter, dated July 24 and recently posted on the FDA’s website, says the company did not adequately investigate a complaint of sterility failure in API batches because it could not provide evidence of the origin of the contamination that may have led to the failure.

ABL did not retrospectively test 14 “retain samples,” which manufacturers routinely keep, from the batches manufactured in the run and did not consider that the sterility of sample bags sent to customers was not tested, according to the letter. The company did not respond to a request for comment by press time.
Drug GMP Report