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FDA Inspection
•Research Instruments Limited•April 13, 2017

Research Instruments Limited – FDA Inspection, Apr 13, 2017

Record Details

This FDA Inspection record concerns Research Instruments Limited, with an inspection on April 13, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Research Instruments Limited
Inspection Date
April 13, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Stephen C. Smith (FDA Associated Person)
View Company Profile

ID · 69565467-9ab2-425b-985a-fe852441f349

Inspection Facts

Inspection number
1010238
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.184DHR - not or inadequately maintained
  3. 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
  4. 21 CFR 820.86Acceptance status
  5. 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Research Instruments Limited

1
DateClassificationOfficeProject area
August 6, 2015NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Research Instruments Limited
  • FDA Inspection 937134 - 2015-08-06

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