FDA 483 - Apollo Health And Beauty Care, Inc. - August 16, 2019

An FDA inspection of Apollo Health And Beauty Care, Inc., an OTC drug manufacturer in North York, revealed significant deficiencies in their quality system and production controls. The firm failed to adequately investigate discrepancies and out-of-specification results, and its quality control unit did not consistently follow established procedures. Furthermore, the company had not completed process validation for several product families and bulk hold times, indicating a lack of robust manufacturing process control.