The FDA issued a warning letter to an over-the-counter drug manufacturer in New Jersey for failing to maintain its facility in a good state of repair and other serious GMP violations.
An agency inspection of the Acino Products plant in Hamilton revealed missing ceiling tiles directly above a mixing tank, an open hopper and a filling machine. The investigator also found that non-dedicated filling equipment used to manufacture drug products was filthy and covered in residue.
Among other failures, the firm lacked records to show that it had validated cleaning procedures for dedicated equipment used to manufacture its clotrimazole topical solution. The FDA investigator was told that the firm used a different cleaning agent than the one identified in its written cleaning procedures.
In addition, the firm lacked data to support microbiological test results for batches of its bisacodyl and phenylephrine suppositories, but it issued a certificate of analysis confirming the results and released the batches. The firm could not say whether samples had been sent to a third-party lab for analysis to support the results.