In the antiseptic world of drug manufacturing, cleanliness is key and outside contamination is a drugmaker’s worst enemy. That’s why, generally speaking, chronic water leaks from the ceiling are a bad thing - a fact an Indian generics maker is having to learn the hard way.
Aurolife, a subsidiary of Aurobindo Pharma, failed to adequately address a raft of issues at its Dayton, New Jersey, plant, including a flood of water leaks and impurity concerns over active pharmaceutical ingredients (APIs) used in one of its generic antipsychotics, the FDA said in a warning letter posted online Tuesday.
In its response, Aurolife pledged to recall unnamed drugs cited in the FDA's Form 483, but the agency found Aurolife's "executive management failed to fully recognize the risks from these leaks" and didn't outline an adequate plan to conduct repairs.
The firm also failed to ensure its API was kept at a constant refrigerated temperature during storage, the FDA wrote.
Source : Fierce Pharma