The FDA hit Genus Lifesciences with a Form 483 following a July inspection of its Allentown, Pa., drug facility, citing inadequate reviews of discrepancies and failure to reject substandard products.
FDA investigators found the company had received four separate consumer complaints of mold or a black substance around the bottle tip of oral drug products since 2016. Two of the four batches were identified as out-of-specification for micro testing, but the facility did not conduct tests to identify the contaminant or its source, and the lots were left in the market until expiration, the agency said.
The facility also received consumer complaints about particulate matter or cloudiness in its Potassium Chloride Oral Solution, but it continued to manufacture and distribute it. It also failed to submit an NDA Field Alert Report within three working days of receiving information about bacteriological contamination of a product, according to the 483.