The FDA has smacked Florida-based Allay Pharmaceuticals with a warning letter for a range of issues related to its tablet manufacturing operations.
The agency inspected Allay’s plant in May and then sent a Form 483 detailing the company’s wrongdoings. In a warning letter posted this week, the FDA scolded the company for not adequately addressing the problems the agency uncovered.
One of the main concerns was related to potency problems. In its warning letter, the FDA stated that Allay failed to provide adequate data showing homogeneity in its products and that the company obtained an out-of-spec result for one of its APIs. The agency said that when its inspector collected three tablets to test, all three were found to be sub-potent.
“Your manufacturing failures indicate that you do not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality,” the FDA chided.
Among the other violations listed, the FDA noted that Allay had failed to adequately investigate batch discrepancies, that the company’s stability testing is not up to snuff, and that Allay was not adequately qualifying API suppliers. Allay was also warned that it is distributing tablets classified as biologics that have not even been approved by the agency.
Given the long list of violations, the agency recommended that Allay work with a CGMP consultant to bring its operations into compliance.
According to the company, Allay offers end-to-end technical services for “all aspects” of pharma operations, including pre-formulation studies, analytical testing and contract manufacturing.
Read the FDA warning letter.
