FDA Inspection
Boston Foundation For SightBoston Foundation For Sight – FDA Inspection, Apr 11, 2011
Record Details
This FDA Inspection record concerns Boston Foundation For Sight, with an inspection on April 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Boston Foundation For Sight
- Inspection Date
- April 11, 2011
- Product Type
- Devices
View Company Profile
ID · 022a068b-3a43-477e-a41b-7d7ed7e28550
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 719062
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Foundation For Sight
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2018 | Not classified | New England District Office | |
| September 28, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 2, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Boston Foundation For Sight
- FDA Inspection 1110894 - 2018-10-19
- FDA Inspection 1030112 - 2017-09-28
- FDA Inspection 545617 - 2008-10-02
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