FDA Inspection
Boston Scientific Corp.Boston Scientific Corp. – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Boston Scientific Corp., with an inspection on January 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Boston Scientific Corp.
- Inspection Date
- January 28, 2011
- Product Type
- Devices
View Company Profile
ID · 8cd1c60d-fdf5-411c-942c-7b812f1b838f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709045
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 820.184DHR - not or inadequately maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Scientific Corp.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2023 | Not classified | New England District Office | |
| October 8, 2018 | Not classified | New England District Office | |
| September 13, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 9, 2017 | Not classified | New England District Office | |
| March 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Boston Scientific Corp.
- FDA Inspection 1198479 - 2023-02-15
- FDA Inspection 1122692 - 2018-10-08
- FDA Inspection 1066822 - 2018-09-13
- FDA Inspection 1051763 - 2017-11-09
- FDA Inspection 924170 - 2015-03-10
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