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FDA Inspection
•Parcus Medical, LLC•February 17, 2017

Parcus Medical, LLC – FDA Inspection, Feb 17, 2017

Record Details

This FDA Inspection record concerns Parcus Medical, LLC, with an inspection on February 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Parcus Medical, LLC
Inspection Date
February 17, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Stanley B. Eugene (Company Rep)
View Company Profile

ID · c25bfd28-675c-415e-83ab-eeea472634fb

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1004673
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.40Procedures not adequately established or maintained

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Parcus Medical, LLC

1
DateClassificationOfficeProject area
August 16, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Parcus Medical, LLC
  • FDA Inspection 844243 - 2013-08-16

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