Drug factory · FDA FEI 1000113778
Bausch & Lomb Incorporated
8500 Hidden River Parkway, Tampa, FL, United States
Serious problems, FDA action at FDA's last inspection, Mar 20, 2026.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
17 drug inspections on record since 2009: 7 with no problems, 7 with problems fixed voluntarily, 3 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 20, 2026 | Serious problems, FDA action | Drug Quality Assurance | — |
| Aug 25, 2023 | No problems found | Drug Quality Assurance | — |
| Jan 30, 2019 | No problems found | Drug Quality Assurance | — |
| Aug 10, 2018 | Serious problems, FDA action | Drug Quality Assurance | 5 |
| May 26, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 25, 2016 | No problems found | Unapproved and Misbranded Drugs | — |
| Feb 25, 2016 | No problems found | Postmarket Surv. and Epidemiology | — |
| Feb 25, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |
| Mar 6, 2015 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | — |
| Mar 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 12, 2013 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | 2 |
| Jul 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 21, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 21, 2012 | No problems found | Bioresearch Monitoring | 2 |
| Oct 25, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2009 | No problems found | Postmarket Surv. and Epidemiology | — |
| Oct 30, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 10, 2018 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not justified. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Jul 12, 2013 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Mar 21, 2012 inspection
- Identification of persons involved, each significant step 21 CFR 211.188(b)(11)
Batch production and control records do not include the identification of the persons performing each significant step in the operation, for each batch of drug product produced. - Identification of persons involved, each significant step 21 CFR 211.188(b)(11)
Batch production and control records do not include the identification of the persons performing each significant step in the operation, for each batch of drug product produced.
Registered with FDA for: analysis; label; manufacture; pack.