FDA Inspection
Amend Surgical, Inc.Amend Surgical, Inc. – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Amend Surgical, Inc., with an inspection on November 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8250c3de-d16a-4d12-995f-8ff417a558cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071519
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Amend Surgical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2025 | Not classified | Florida District Office |
Other documents for Amend Surgical, Inc.
- FDA Inspection 1263898 - 2025-03-06
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