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FDA Inspection
•Aesica Pharmaceutical GmbH•November 11, 2011

Aesica Pharmaceutical GmbH – FDA Inspection, Nov 11, 2011

Record Details

This FDA Inspection record concerns Aesica Pharmaceutical GmbH, with an inspection on November 11, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Aesica Pharmaceutical GmbH
Inspection Date
November 11, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 6cc1eb00-373b-489f-8362-2f9f7cf09e41

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
759369
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

1
  1. 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Aesica Pharmaceutical GmbH

4
DateClassificationOfficeProject area
September 12, 2024VAIDrug Quality Assurance
July 1, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 20, 2017NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 17, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Aesica Pharmaceutical GmbH
  • FDA Inspection 1306304 - 2024-09-12
  • FDA Inspection 1190265 - 2021-07-01
  • FDA Inspection 1032046 - 2017-09-20
  • FDA Inspection 866229 - 2014-01-17

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