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FDA Inspection
•Mesa Laboratories, Inc.•March 5, 2015

Mesa Laboratories, Inc. – FDA Inspection, Mar 5, 2015

Record Details

This FDA Inspection record concerns Mesa Laboratories, Inc., with an inspection on March 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
Mesa Laboratories, Inc.
Inspection Date
March 5, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · d5cc5cf7-14ad-46fc-9b98-d367f6023328

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
917352
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

5
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  2. 21 CFR 820.25(b)Training - Lack of or inadequate procedures
  3. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  4. 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
  5. 21 CFR 820.70(i)Software validation for automated processes

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mesa Laboratories, Inc.

2
DateClassificationOfficeProject area
March 16, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
August 29, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Mesa Laboratories, Inc.
  • FDA Inspection 1044777 - 2018-03-16
  • FDA Inspection 796546 - 2012-08-29

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