Fidelio Healthcare Limburg GmbH, Limburg, Germany – FDA Inspections

Inspection records and compliance data for Fidelio Healthcare Limburg GmbH in Limburg. 5 FDA inspections on record, 2 Form 483s, last inspected November 17, 2023.

Company Profile

This profile covers Fidelio Healthcare Limburg GmbH based in Limburg, Germany.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 3
NAI: 1
Unclassified: 1
Form 483s: 2
Warning letters: 0

First inspected September 21, 2011. Last inspected November 17, 2023.

Most cited issue areas

Annual visual exams of drug products1 inspection
Calibration/Inspection/Checking not done1 inspection
Complete test data included in records1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
November 17, 2023	Not classified	Human Drugs	1223517
July 20, 2022	VAI	Human Drugs · Drug Quality Assurance	1234400
February 2, 2017	VAI	Human Drugs · Drug Quality Assurance	999720
May 23, 2014	VAI	Human Drugs · Drug Quality Assurance	889394
September 21, 2011	NAI	Human Drugs · Drug Quality Assurance	748702

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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