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FDA Inspection
•Uno Laser Inc.•November 20, 2018

Uno Laser Inc. – FDA Inspection, Nov 20, 2018

Record Details

This FDA Inspection record concerns Uno Laser Inc., with an inspection on November 20, 2018, issued by the New York District Office, covering medical devices & rad health.

Company
Uno Laser Inc.
Inspection Date
November 20, 2018
Product Type
Medical Devices & Rad Health
Office
New York District Office
Person
  • Andrew J. Garufi (Issuing Officer)
View Company Profile

ID · 7f1f610f-e91c-4e72-aba3-433cb20cb1cc

Inspection Facts

Inspection number
1072320
FDA center
Medical Devices & Rad Health
Project area
Radiation Control and Health Safety Act
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 1002.30(a)(1)Quality control procedures
  2. 21 CFR 1002.30(a)(2)Results of tests
  3. 21 CFR 1040.10(f)(10)Manual reset not provided

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Uno Laser Inc.

1
DateClassificationOfficeProject area
January 25, 2015OAICenter for Devices and Radiological HealthRadiation Control and Health Safety Act
Other documents for Uno Laser Inc.
  • FDA Inspection 920084 - 2015-01-25

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