FDA Inspection
Bausch & Lomb IncorporatedBausch & Lomb Incorporated – FDA Inspection, Aug 10, 2018
Record Details
This FDA Inspection record concerns Bausch & Lomb Incorporated, with an inspection on August 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Ileana Barreto-Pettit (Issuing Officer)
- Latorie S. Jones (FDA Associated Person)
View Company Profile
ID · 26102076-72bd-442a-bd9d-50d01bcbccaf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1061913
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| May 26, 2017 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| 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 1015001 - 2017-05-26
- FDA Inspection 967714 - 2016-02-25
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