FDA Inspection
Bausch & Lomb IncorporatedBausch & Lomb Incorporated – FDA Inspection, Jun 25, 2010
Record Details
This FDA Inspection record concerns Bausch & Lomb Incorporated, with an inspection on June 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bausch & Lomb Incorporated
- Inspection Date
- June 25, 2010
- Product Type
- Devices
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ID · 9dac2d40-c8c8-4513-99d4-5db2662d7ed4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669164
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
Showing 10 of 12 citations.
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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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