FDA Inspection
Boston Scientific CorporationBoston Scientific Corporation – FDA Inspection, Sep 8, 2014
Record Details
This FDA Inspection record concerns Boston Scientific Corporation, with an inspection on September 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 8, 2014
- Product Type
- Devices
View Company Profile
ID · baacf374-dc0f-45e1-8e46-b686ce7eed03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894188
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
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