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FDA Inspection
•Laxmi Dental Lab Usa Inc•May 3, 2013

Laxmi Dental Lab Usa Inc – FDA Inspection, May 3, 2013

Record Details

This FDA Inspection record concerns Laxmi Dental Lab Usa Inc, with an inspection on May 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Laxmi Dental Lab Usa Inc
Inspection Date
May 3, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · c4fd1c76-9b18-4526-ba60-eb15b47ebe87

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
829966
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

5
  1. 21 CFR 820.40Lack of procedures, or not maintained
  2. 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
  3. 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
  4. 21 CFR 820.140Lack of or inadequate procedures for handling
  5. 21 CFR 820.198(g)Foreign complaint files

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Laxmi Dental Lab Usa Inc

1
DateClassificationOfficeProject area
August 19, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Laxmi Dental Lab Usa Inc
  • FDA Inspection 845226 - 2013-08-19

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