FDA Inspection
Boston Scientific Neuromodulation CorporationBoston Scientific Neuromodulation Corporation – FDA Inspection, Apr 8, 2026
Record Details
This FDA Inspection record concerns Boston Scientific Neuromodulation Corporation, with an inspection on April 8, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
- Inspection Date
- April 8, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · b9815226-8abe-4bb0-8e8f-e01b0a4c7696
Inspection Facts
- Inspection number
- 1276849
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued, view the record
FDA Citations
11- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.3Impact of changes to purchased product not determined
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.3.3Appropriate action not taken for nonconforming product after delivery or use
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Other FDA inspections of Boston Scientific Neuromodulation Corporation
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2017 | Not classified | Los Angeles District Office | |
| November 17, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 22, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 29, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Boston Scientific Neuromodulation Corporation
- FDA Inspection 1034596 - 2017-07-20
- FDA Inspection 994022 - 2016-11-17
- FDA Inspection 955462 - 2016-01-22
- FDA Inspection 936228 - 2015-07-29
- FDA Inspection 828898 - 2013-04-25
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