Bausch & Lomb, Inc.
Form 483 issued March 20, 2026 · Tampa, Florida
- Inspection
- Mar 12 – Mar 20, 2026
- Investigators
- Damaris Y. Hernandez· Mickell Smith· Santos E. Camara
- Observations
- 3
- Pages
- 8
- FEI number
- 1000113778
In short: On March 20, 2026, FDA issued a Form 483 with 3 observations to Bausch & Lomb, Inc. in Tampa, Florida (FEI 1000113778) after an inspection that ran Mar 12 – Mar 20, 2026. The investigators were Damaris Y. Hernandez, Mickell Smith and Santos E. Camara. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint records are deficient in that they do not include the findings of…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Written procedures are not followed for the receipt…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmBausch & Lomb, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bausch & Lomb, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, production and materials. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Bausch & Lomb, Inc.?
Damaris Y. Hernandez, Mickell Smith and Santos E. Camara are named on this Form 483, for the inspection of Mar 12 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was Bausch & Lomb, Inc. inspected by FDA?
The inspection ran Mar 12 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for Bausch & Lomb, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.