1Aseptic processing and sterility assurance
Aseptic Processing areas are deficient in that the floors, walls, ceilings, and work surfaces are not smooth and/or hard surfaces that are easily cleanable.
Inspection Record
Apollo Care, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the <Redacted B4> process.
About this record
Extracted automatically from the document US FDA published on 2022-05-13. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
