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FDA Inspection
•Tcoag Deutschland GmbH•December 6, 2018

Tcoag Deutschland GmbH – FDA Inspection, Dec 6, 2018

Record Details

This FDA Inspection record concerns Tcoag Deutschland GmbH, with an inspection on December 6, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Tcoag Deutschland GmbH
Inspection Date
December 6, 2018
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · bf0d4894-28b2-40b7-87d7-31aa75eb3f7b

Inspection Facts

Inspection number
1073524
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.22Quality audits - Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Tcoag Deutschland GmbH

1
DateClassificationOfficeProject area
April 12, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Tcoag Deutschland GmbH
  • FDA Inspection 969389 - 2016-04-12

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