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FDA Inspection
•Asap Endoscopic Products GmbH•December 13, 2018

Asap Endoscopic Products GmbH – FDA Inspection, Dec 13, 2018

Record Details

This FDA Inspection record concerns Asap Endoscopic Products GmbH, with an inspection on December 13, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Asap Endoscopic Products GmbH
Inspection Date
December 13, 2018
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · 2cf25905-43a5-412b-a908-00379e080e79

Inspection Facts

Inspection number
1074271
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.20(c)Management review - Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Asap Endoscopic Products GmbH

2
DateClassificationOfficeProject area
June 19, 2026Not classifiedOffice of Inspections and InvestigationsCompliance: Devices
July 8, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Asap Endoscopic Products GmbH
  • FDA Inspection 1322722 - 2026-06-19
  • FDA Inspection 988487 - 2016-07-08

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