FDA Inspection
NuVasive Specialized Orthopedics, Inc.NuVasive Specialized Orthopedics, Inc. – FDA Inspection, May 6, 2024
Record Details
This FDA Inspection record concerns NuVasive Specialized Orthopedics, Inc., with an inspection on May 6, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c35a986f-b5ee-421d-9854-a2cbd593b3ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234447
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Showing 10 of 12 citations.
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Other FDA inspections of NuVasive Specialized Orthopedics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for NuVasive Specialized Orthopedics, Inc.
- FDA Inspection 872999 - 2014-02-20
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