FDA Inspection
Bausch & Lomb IncorporatedBausch & Lomb Incorporated – FDA Inspection, Dec 17, 2010
Record Details
This FDA Inspection record concerns Bausch & Lomb Incorporated, with an inspection on December 17, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bausch & Lomb Incorporated
- Inspection Date
- December 17, 2010
- Product Type
- Drugs
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ID · e4b195fe-decf-4b6c-b836-ec99fc2586e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 704851
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Bausch & Lomb Incorporated
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2025 | OAI | Atlanta District Office | Drug Quality Assurance |
| September 20, 2019 | Not classified | Atlanta District Office | |
| August 28, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 5, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bausch & Lomb Incorporated
- FDA Inspection 1250877 - 2025-02-27
- FDA Inspection 1127085 - 2019-09-20
- FDA Inspection 1073462 - 2018-08-28
- FDA Inspection 1031429 - 2017-09-15
- FDA Inspection 988726 - 2016-10-05
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