Inspection Record

Medi-Fare Drug — FDA 483 Findings

US FDAInspected 2023-05-26Published 2024-03-21 4 findingsMaterial and supplier controlAseptic processing and sterility assuranceLabeling and packaging

Inspectors Jared P StevensThe inspectors who signed the published document.Inspector lookup

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

Findings

1Material and supplier control

Reports of analysis from component suppliers are accepted in lieu of testing each component for confonnity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring enviromnental conditions.

3Labeling and packaging

Samples of representative lmits were not visually examined for correct labeling at the completion of finishing operations.

4Material and supplier control

The identity of each component of a drng product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

About this record

Extracted automatically from the document US FDA published on 2024-03-21. 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.

Medi-Fare Drug company profile — full history US FDA documents, 2024 Go to Findings search