FDA Inspection
MARC PRO, INC.MARC PRO, INC. – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns MARC PRO, INC., with an inspection on February 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e63c70e2-5037-4dc0-a1da-fc43222b4f8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040263
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(a)Design control - no procedures
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Other FDA inspections of MARC PRO, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MARC PRO, INC.
- FDA Inspection 1196573 - 2023-01-11
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