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FDA Inspection
•Metro Optics of Austin, Inc.•February 26, 2016

Metro Optics of Austin, Inc. – FDA Inspection, Feb 26, 2016

Record Details

This FDA Inspection record concerns Metro Optics of Austin, Inc., with an inspection on February 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Metro Optics of Austin, Inc.
Inspection Date
February 26, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · f40b332f-a4c6-412a-b643-3fed037a3374

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
962762
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

8
  1. 21 CFR 820.80(b)Incoming acceptance records, documentation
  2. 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
  3. 21 CFR 820.100(a)Lack of or inadequate procedures
  4. 21 CFR 820.184Lack of or inadequate DHR procedures
  5. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  6. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  7. 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
  8. 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Metro Optics of Austin, Inc.

3
DateClassificationOfficeProject area
October 15, 2026VAICenter for Devices and Radiological HealthCompliance: Devices
February 22, 2024Not classifiedDallas District Office
September 19, 2018NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Metro Optics of Austin, Inc.
  • FDA Inspection 1342276 - 2026-10-15
  • FDA Inspection 1232494 - 2024-02-22
  • FDA Inspection 1068595 - 2018-09-19

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