FDA Inspection
Florida Probe CorporationFlorida Probe Corporation – FDA Inspection, Feb 14, 2017
Record Details
This FDA Inspection record concerns Florida Probe Corporation, with an inspection on February 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b58b6c2c-5f98-4090-8db4-8562fd4ae66a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004504
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Florida Probe Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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