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FDA Inspection
•Elite Medical Supply of New York, LLC•December 18, 2017

Elite Medical Supply of New York, LLC – FDA Inspection, Dec 18, 2017

Record Details

This FDA Inspection record concerns Elite Medical Supply of New York, LLC, with an inspection on December 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Elite Medical Supply of New York, LLC
Inspection Date
December 18, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Matthew D. Schnittker (Issuing Officer)
View Company Profile

ID · e959d250-a8da-47a3-8307-64a7ce4dfb7f

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1035493
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.30(a)Design control - no procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Elite Medical Supply of New York, LLC

2
DateClassificationOfficeProject area
February 11, 2020VAICenter for Devices and Radiological HealthCompliance: Devices
August 14, 2014VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Elite Medical Supply of New York, LLC
  • FDA Inspection 1117839 - 2020-02-11
  • FDA Inspection 891846 - 2014-08-14

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