FDA Inspection
Sarasota Medical Products, Inc.Sarasota Medical Products, Inc. – FDA Inspection, Jun 12, 2019
Record Details
This FDA Inspection record concerns Sarasota Medical Products, Inc., with an inspection on June 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9c6cf79e-fbaf-4f82-983d-5e15a1aa8ee2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094810
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.184DHR content
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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Other FDA inspections of Sarasota Medical Products, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2024 | Not classified | Florida District Office |
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