FDA Inspection
Bausch & Lomb IncorporatedBausch & Lomb Incorporated – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns Bausch & Lomb Incorporated, with an inspection on May 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Ileana Barreto-Pettit (Issuing Officer)
- Jennifer L. Huntington (FDA Associated Person)
- Ruo H. Xu (Issuing Officer)
- Wendy G. Tan
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ID · 8c2f6020-98e3-45a1-8605-82a171aada39
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015001
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(1)Description and Identification of Samples
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Bausch & Lomb Incorporated
10| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2026 | Not classified | Florida District Office | |
| August 25, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 10, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bausch & Lomb Incorporated
- FDA Inspection 1304548 - 2026-03-20
- FDA Inspection 1218198 - 2023-08-25
- FDA Inspection 1082137 - 2019-01-30
- FDA Inspection 1061913 - 2018-08-10
- FDA Inspection 967714 - 2016-02-25
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