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FDA Inspection
•Anteis Sa•February 15, 2013

Anteis Sa – FDA Inspection, Feb 15, 2013

Record Details

This FDA Inspection record concerns Anteis Sa, with an inspection on February 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Anteis Sa
Inspection Date
February 15, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · dec703e2-5878-45dd-ab25-9390a9be75e3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
823159
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Anteis Sa

2
DateClassificationOfficeProject area
February 25, 2026Not classifiedOffice of Inspections and InvestigationsPostmarket Assurance: Medical Devices
November 4, 2009NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Anteis Sa
  • FDA Inspection 1305880 - 2026-02-25
  • FDA Inspection 630082 - 2009-11-04

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