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FDA Inspection
•Siegfried Hameln GmbH•July 25, 2014

Siegfried Hameln GmbH – FDA Inspection, Jul 25, 2014

Record Details

This FDA Inspection record concerns Siegfried Hameln GmbH, with an inspection on July 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Siegfried Hameln GmbH
Inspection Date
July 25, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 098b0d0c-6d3f-4682-8290-157ece943b50

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
887446
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  2. 21 CFR 211.25(a)GMP Training Frequency
  3. 21 CFR 211.180(e)Records reviewed annually

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Siegfried Hameln GmbH

5
DateClassificationOfficeProject area
September 1, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 24, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 1, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 14, 2012OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 9, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Siegfried Hameln GmbH
  • FDA Inspection 1203347 - 2022-09-01
  • FDA Inspection 1050123 - 2018-04-24
  • FDA Inspection 987428 - 2016-07-01
  • FDA Inspection 786813 - 2012-06-14
  • FDA Inspection 637807 - 2009-11-09

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