FDA 483 - Apollo Health And Beauty Care, Inc. - April 15, 2022

Apollo Health And Beauty Care, Inc., an OTC drug manufacturer in North York, was cited for failing to perform appropriate microbiological testing. The firm did not test for Burkholderia cepacia in its water testing program or aqueous OTC drug products, leading to the release of hand sanitizer without this critical testing. This indicates a significant lapse in quality control for drug products required to be free of objectionable microorganisms.