FDA Inspection
SPINEUP INCSPINEUP INC – FDA Inspection, Oct 31, 2023
Record Details
This FDA Inspection record concerns SPINEUP INC, with an inspection on October 31, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a0cb3b9b-86b2-43e3-90a5-03401c9ea681
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221595
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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