Drug factory · FDA FEI 1317628
Bausch & Lomb Incorporated
1400 N. Goodman Street, Rochester, NY, United States
No problems found at FDA's last inspection, Jul 30, 2025.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Besifloxacin | Tests it | Bausch & Lomb Incorporated | 24208-446 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 30, 2025 | No problems found | Drug Quality Assurance | — |
| Nov 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 10, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 23, 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.
Nov 25, 2019 inspection
- 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. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the processing and holding of a drug product are not maintained in a good state of repair.
Mar 24, 2017 inspection
- Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of instruments and recording devices not meeting established specifications was observed. Electronic records are used, but they do not meet system access limitation, audit trail and operational system check requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Nonconforming product control 21 CFR 820.90(a)
Products that do not conform to specifications are not adequately controlled.
Registered with FDA for: analysis.