FDA Inspection
Bausch & Lomb IncBausch & Lomb Inc – FDA Inspection, May 17, 2012
Record Details
This FDA Inspection record concerns Bausch & Lomb Inc, with an inspection on May 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bausch & Lomb Inc
- Inspection Date
- May 17, 2012
- Product Type
- Devices
View Company Profile
ID · 7bcf7ca4-5aab-4550-9359-5225a1103362
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 782300
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bausch & Lomb Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 8, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 10, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 15, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bausch & Lomb Inc
- FDA Inspection 1107226 - 2019-10-08
- FDA Inspection 978030 - 2016-06-10
- FDA Inspection 826558 - 2013-03-15
- FDA Inspection 784537 - 2012-06-01
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