Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality.
Inspection Record
Age Management Institute Santa Barbara — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
Sporicidal agents ,vere not used in your production area.
Non-microbial contamination was observed in your production area.
The aseptic processing areas had difficult to clean equipment or surfaces.
About this record
Extracted automatically from the document US FDA published on 2021-09-10. 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.
