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# Bausch & Lomb Inspection FDA-483 Out
- URL: https://www.fdaweb.com/bausch-lomb-inspection-fda-483-out/
- Published: 2016-09-06T12:00:00.000Z
- Updated: 2026-09-14T21:29:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136702

FDA has just released the FDA-483 that was issued at the conclusion of a 2/8-2/25 inspection at Bausch & Lomb’s facility in Tampa, FL. Specific violations noted on the form included: 

- failing to include conclusions and follow-up in written records of investigations into unexplained discrepancies;
- failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failing to maintain at appropriate intervals equipment and utensils to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product; and
- failing to establish control procedures that monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.