1Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
Inspection Record
Westlab Pharmacy, Inc. dba Westlab Pharmacy — FDA 483 Findings
Inspectors Jennifer L HuntingtonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
3Material and supplier control
Written procedures are lacking which describe in sufficient detail the identification, sampling, testing, approval and rejection of components, drng product containers and closures.
4Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing area was located within a non-classified room (segregated production area).
5Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
6Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
7Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean equipment or surface.
8Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hands.
9Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
