Inspection Record

Bausch and Lomb Incorporated — FDA 483 Findings

US FDAInspected 2026-03-20Published 2026-07-24 3 findingsStability and storageAseptic processing and sterility assuranceComplaint and recall handling

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

Findings

1Stability and storage

Written procedures are not followed for the receipt, storage and handling of.

2Aseptic processing and sterility assurance

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

3Complaint and recall handling

Complaint records are deficient in that they do not include the findings ofthe investigation and follow-up.

About this record

Extracted automatically from the document US FDA published on 2026-07-24. 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.

Bausch and Lomb Incorporated company profile — full history US FDA documents, 2026 Go to Findings search