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.
The firm’s calibration practices were also found to be inadequate. For example, it failed to calibrate analytical balances and did not have equipment calibration procedures for all analytical laboratory HPLCs for commercial use. It also lacked procedures and documentation for monitoring a laboratory water system.
The facility also lacked a long-term stability program. It did not place at least one representative D-Cal lot in OTC packaging configuration in the program in 2015.
The firm also failed to follow procedures for proper warehousing of drug products. It did not label a D-Cal lot as rejected and place it in the rejection area — it was found in the holding area instead. It also did not have procedures to address the handling of materials or finished products that were placed on QA hold.
In addition, reserve samples from representative batches or sample lots of products were not adequately examined visually for deterioration, and the firm had no visual inspection data for the two products.