Safecor Health Slammed With 13-Item 483

The FDA slapped pharmaceutical manufacturer and repackager Safecor Health with a 13-item Form 483 citing lapses in quality control, batch specification and written procedures.

An Oct. 5 to Oct. 27, 2015, inspection revealed the Woburn, Mass.-based Safecor’s quality control unit lacked the responsibility to review and approve components, drug product containers, packing and drug products. This includes raw materials, returned or rejected materials and equipment calibration and qualification processes.

The agency chided the company for failing to thoroughly review whether unexplained discrepancies, as well as the failure of a batch or its components to meet any of its specifications.