Inspection Record

Walter’s Pharmacy — FDA 483 Findings

US FDAInspected 2016-03-28Published 2024-01-17 5 findingsAseptic processing and sterility assuranceMaterial and supplier controlContamination controlStability and storage

Inspectors James M MasonThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.

2Material and supplier control

Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

4Contamination control

Protective apparel is not wor n as necessary to protect drug products from contamination.

5Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

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.

Walter’s Pharmacy company profile — full history US FDA documents, 2024 Go to Findings search