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FDA Inspection
•Cambridge Sensors Limited•May 10, 2019

Cambridge Sensors Limited – FDA Inspection, May 10, 2019

Record Details

This FDA Inspection record concerns Cambridge Sensors Limited, with an inspection on May 10, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Cambridge Sensors Limited
Inspection Date
May 10, 2019
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Melanie W. Pishnery
View Company Profile

ID · ffdbf092-12c4-45a2-bb2c-a0fbfc6a0f91

Inspection Facts

Inspection number
1089449
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
  2. 21 CFR 806.20(b)(4)Justification for not reporting

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cambridge Sensors Limited

1
DateClassificationOfficeProject area
July 19, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Cambridge Sensors Limited
  • FDA Inspection 799290 - 2012-07-19

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