FDA Inspection
Applied Medical Coatings, LLCApplied Medical Coatings, LLC – FDA Inspection, Jun 27, 2025
Record Details
This FDA Inspection record concerns Applied Medical Coatings, LLC, with an inspection on June 27, 2025, issued by the New York District Office, covering medical devices & rad health.
- Inspection Date
- June 27, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 6d8109a4-46c3-4561-89c0-0b8d0abc0d59
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1275672
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
3- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Applied Medical Coatings, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Applied Medical Coatings, LLC
- FDA Inspection 1154743 - 2021-10-13
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