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FDA Inspection
•Cobeg Inc•December 4, 2008

FDA Inspection 550159 - Cobeg Inc - December 04, 2008

Record Details

This FDA Inspection record concerns Cobeg Inc, with an inspection on December 4, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company
Cobeg Inc
Inspection Date
December 4, 2008
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 1b61fc31-e904-4a4a-bc70-de050d2e0683

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
550159
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

5
  1. 21 CFR 820.198(a)General
  2. 21 CFR 820.70(c)Environmental control system periodic inspections
  3. 21 CFR 820.184Lack of or inadequate DHR procedures
  4. 21 CFR 820.90(a)Nonconforming product control
  5. 21 CFR 820.180(b)Retention period

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cobeg Inc

2
DateClassificationOfficeProject area
June 24, 2010NAICenter for Devices and Radiological HealthCompliance: Devices
February 4, 2009OAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Cobeg Inc
  • FDA Inspection 671756 - 2010-06-24
  • FDA Inspection 559384 - 2009-02-04

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