FDA Inspection
Exactech Sarasota, Inc.Exactech Sarasota, Inc. – FDA Inspection, Jul 25, 2025
Record Details
This FDA Inspection record concerns Exactech Sarasota, Inc., with an inspection on July 25, 2025, issued by the Florida District Office, covering medical devices & rad health.
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ID · 9d577034-d400-42bb-8ff6-a936fb3cda09
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1276540
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Exactech Sarasota, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2025 | Not classified | Florida District Office | |
| August 25, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Exactech Sarasota, Inc.
- FDA Inspection 1279947 - 2025-07-25
- FDA Inspection 892412 - 2014-08-25
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