FDA Inspection
Elite Medical Supply of New York, LLCElite Medical Supply of New York, LLC – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns Elite Medical Supply of New York, LLC, with an inspection on November 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 448b7492-a346-4862-a947-fc3d7957e382
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071862
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of Elite Medical Supply of New York, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2024 | Not classified | New Orleans District Office |
Other documents for Elite Medical Supply of New York, LLC
- FDA Inspection 1252909 - 2024-10-22
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