The FDA issued a warning letter to OTC drugmaker Apollo Health and Beauty Care for serious CGMP lapses at its North York, Ontario facility.
The agency found multiple discrepancies between human-machine interface (HMI) data and batch record entries made by operators during an investigation of an out-of-specification product lot.
Following the agency’s inspection, the company said it would randomly select batch records to investigate any discrepancies. But the FDA said the company needed to conduct a full evaluation of the discrepancies and of operators failing to follow batch record procedures.
The firm also failed to trace the root cause of the problem and to check if the inconsistencies affected other records, the agency said.