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FDA Inspection
•Work Inc.•April 14, 2011

Work Inc. – FDA Inspection, Apr 14, 2011

Record Details

This FDA Inspection record concerns Work Inc., with an inspection on April 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Work Inc.
Inspection Date
April 14, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 2ed04abb-65a2-4fad-a372-b067a7d9bd3a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
721927
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

4
  1. 21 CFR 820.70(g)(2)Periodic equipment inspections
  2. 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
  3. 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
  4. 21 CFR 820.22Quality Audit/Reaudit - documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Work Inc.

1
DateClassificationOfficeProject area
September 14, 2017NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Work Inc.
  • FDA Inspection 1028551 - 2017-09-14

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