Inspection Record

Age Management Institute Santa Barbara — FDA 483 Findings

US FDAInspected 2021-04-12Published 2021-09-10 4 findingsMaterial and supplier controlOther quality systemContamination controlAseptic processing and sterility assurance

View the regulator's official source The source document is always the basis for judgement.

Findings

1Material and supplier control

Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality.

2Other quality system

Sporicidal agents ,vere not used in your production area.

3Contamination control

Non-microbial contamination was observed in your production area.

4Aseptic processing and sterility assurance

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.

Other records for this company

Age Management Institute Santa Barbara findings history — including this company's other documents US FDA documents, 2021 Go to Findings search