Umforana GmbH & Co. KG, Wiesbaden, Germany – FDA Inspections

Inspection records and compliance data for Umforana GmbH & Co. KG in Wiesbaden. 3 FDA inspections on record, last inspected April 12, 2022.

Company Profile

This profile covers Umforana GmbH & Co. KG based in Wiesbaden, Germany.

FDA Inspection History

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

First inspected September 13, 2012. Last inspected April 12, 2022.

Most cited issue areas

Changes to Procedures Not Reviewed, Approved1 inspection
Complete test data included in records1 inspection
Lab controls established, including changes1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
April 12, 2022	VAI	Human Drugs · Drug Quality Assurance	1177330
June 16, 2015	VAI	Human Drugs · Drug Quality Assurance	935372
September 13, 2012	NAI	Human Drugs · Drug Quality Assurance	800990

FDA documents

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

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