FDA Inspection
Bausch & Lomb Surgical, Inc.Bausch & Lomb Surgical, Inc. – FDA Inspection, Apr 5, 2017
Record Details
This FDA Inspection record concerns Bausch & Lomb Surgical, Inc., with an inspection on April 5, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ad28124e-f8f7-4263-9c30-bc5de33f22d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008783
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Bausch & Lomb Surgical, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | Not classified | Florida District Office | |
| November 3, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 18, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bausch & Lomb Surgical, Inc.
- FDA Inspection 1248950 - 2024-06-28
- FDA Inspection 1030850 - 2017-11-03
- FDA Inspection 950005 - 2015-11-30
- FDA Inspection 926666 - 2015-05-18
- FDA Inspection 841984 - 2013-07-22
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