Adulterated products and contamination risks landed Columbia, Missouri compounder Apollo Care a warning letter from the FDA, in a follow up to a Form 483 report the agency issued after a March 2018 inspection.
The FDA investigator found dirt and debris on the roofs of ISO 5 laminar air flow (LAF) hoods and noted that aseptic production was conducted within LAF hoods despite having work surfaces with cracks and chips at their edges. The damaged surfaces created potential contamination risks and cleaning difficulties, the agency said.
In addition, the facility continued aseptic production within ISO 5 LAF hoods despite multiple HEPA filter leaks being found in the ISO 7 cleanroom during certifications.
The firm also manufactured products intended to be sterile in an area not equipped to properly protect against contamination risks, the agency said, citing the firm for failing to perform adequate smoke studies under dynamic conditions to show its ISO 5 area had unidirectional airflow.