FDA 483 - Apollo Health And Beauty Care, Inc. - April 03, 2020

Apollo Health And Beauty Care, Inc. in Toronto, Canada, received a Form 483 following an inspection from March 30 to April 3, 2020. The inspection revealed significant deficiencies in laboratory controls, quality system procedures, and investigation processes. Key issues included inadequate product release testing, poor documentation of lab controls, failure to investigate discrepancies, and a quality unit that did not fully follow or enforce written procedures, including those for OOS results, data review, and stability testing.