FDA Inspection
Elite Medical Supply of New York, LLCElite Medical Supply of New York, LLC – FDA Inspection, Aug 14, 2014
Record Details
This FDA Inspection record concerns Elite Medical Supply of New York, LLC, with an inspection on August 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 14, 2014
- Product Type
- Devices
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ID · 0c5d8801-9565-4273-bbb1-ff0c14664c76
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891846
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.20(c)Management review dates
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elite Medical Supply of New York, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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