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FDA Inspection
•Curbell Medical Products, Inc.•March 27, 2017

Curbell Medical Products, Inc. – FDA Inspection, Mar 27, 2017

Record Details

This FDA Inspection record concerns Curbell Medical Products, Inc., with an inspection on March 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Curbell Medical Products, Inc.
Inspection Date
March 27, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Matthew D. Schnittker (Issuing Officer)
View Company Profile

ID · fcaa0dcf-e46d-4088-ad79-1590d0a3745e

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1006300
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Curbell Medical Products, Inc.

2
DateClassificationOfficeProject area
October 9, 2014NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
April 9, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Curbell Medical Products, Inc.
  • FDA Inspection 900170 - 2014-10-09
  • FDA Inspection 776738 - 2012-04-09

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