FDA Inspection
Boston Scientific Corp.Boston Scientific Corp. – FDA Inspection, Feb 12, 2009
Record Details
This FDA Inspection record concerns Boston Scientific Corp., with an inspection on February 12, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Boston Scientific Corp.
- Inspection Date
- February 12, 2009
- Product Type
- Devices
View Company Profile
ID · 37626858-33ab-4252-a0c7-ce1980a91cad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 564161
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(d)Quarantine of finished devices
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.100(a)Lack of or inadequate procedures
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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