FDA Warns N.J. Drugmaker for Subpar Quality Unit
New Jersey drugmaker Health Pharma USA drew a warning letter from the FDA for serious lapses in its quality unit and poor batch records.
An FDA inspection of the facility revealed that the quality unit wasn’t making sure that its products met identity, strength, quality and purity requirements.
Specifically, the agency called out the drugmaker for shipping products before the quality unit reviewed them, noting one lot of aspirin 81mg that was shipped before final quality review, and lots of aspirin 81mg and acetaminophen 325mg were delivered despite incomplete quality testing.
The agency also flagged inadequate process validations for aspirin and acetaminophen products, and not routinely performing identity testing for incoming product components.