FDA Inspection
Salvere Medical, LLCSalvere Medical, LLC – FDA Inspection, Feb 6, 2019
Record Details
This FDA Inspection record concerns Salvere Medical, LLC, with an inspection on February 6, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d84bbaf6-dc7e-46ef-aaaf-2899bc59b2a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078388
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.50(a)(2)Supplier oversight
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