A&Z Pharmaceutical Cited for Calibration and Batch Deficiencies

The FDA issued A&Z Pharmaceutical a Form 483 for deficiencies at its Hauppauge, New York facility that included improper storage conditions, poor calibration practices and failure to review batch failures.

The agency’s November inspection found that improperly stored drug products were released for commercial distribution. Although red specks were observed in the products, the firm failed to reject the affected lots and released them for distribution without satisfactory scientific justification, the agency said.

Black specks were found in multiple lots of the firm’s OTC calcium products D-Cal and D-Cal Kids, but they were also released for commercial distribution without proper analysis.