FDA Releases 5-page Form 483 to Leesar Inc.

FDA has released a five-page Form FDA-483 issued to Leesar Inc. following a 10/2021 inspection of the Fort Myers, FL outsourcing facility. For example, the agency said the firm failed to thoroughly review an out-of-specification potency test result for a lot of vancomycin 1.5g. Despite its contract laboratory reporting the OOS result, the firm’s quality unit approved the product for release without proper justification to the investigation and there was no additional follow up with any associated batches, the inspection form says.

The inspection also cited the company over its written procedures not being established to describe the tests to be conducted on appropriate samples of in-process materials of each batch. Additionally, the agency says the firm’s master production and control records are deficient in that they do not include a statement of theoretical yield and yield percentages.