Aesica Pharmaceuticals GmbH, Zwickau, Germany – FDA Inspections

Inspection records and compliance data for Aesica Pharmaceuticals GmbH in Zwickau. 5 FDA inspections on record, 1 Form 483, last inspected August 31, 2023.

Company Profile

This profile covers Aesica Pharmaceuticals GmbH based in Zwickau, Germany.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 4
NAI: 1
Form 483s: 1
Warning letters: 0

First inspected November 8, 2011. Last inspected August 31, 2023.

Most cited issue areas

Investigations of discrepancies, failures2 inspections
Absence of Written Procedures1 inspection
Complete test data included in records1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
August 31, 2023	VAI	Human Drugs · Drug Quality Assurance	1277716
August 30, 2019	NAI	Human Drugs · Drug Quality Assurance	1105950
December 2, 2016	VAI	Human Drugs · New Drug Evaluation	994783
June 20, 2014	VAI	Human Drugs · Drug Quality Assurance	887354
November 8, 2011	VAI	Human Drugs · Drug Quality Assurance	759166

FDA documents

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

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