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FDA Inspection
•Ferring GmbH•October 26, 2012

Ferring GmbH – FDA Inspection, Oct 26, 2012

Record Details

This FDA Inspection record concerns Ferring GmbH, with an inspection on October 26, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Ferring GmbH
Inspection Date
October 26, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 6d0c7376-9a8f-40c2-b136-09e399640c1a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
806543
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

6
  1. 21 CFR 211.25(a)Training , Education , Experience overall
  2. 21 CFR 211.84(d)(3)Establish reliability of supplier"s C of A
  3. 21 CFR 211.113(b)Procedures for sterile drug products
  4. 21 CFR 211.192Investigations of discrepancies, failures
  5. 21 CFR 211.56(b)Written sanitation procedures lacking
  6. 21 CFR 211.56(b)Written sanitation procedures not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ferring GmbH

5
DateClassificationOfficeProject area
September 30, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 23, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 27, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 11, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 19, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Ferring GmbH
  • FDA Inspection 1168037 - 2021-09-30
  • FDA Inspection 1100433 - 2019-08-23
  • FDA Inspection 1004997 - 2017-01-27
  • FDA Inspection 907930 - 2014-11-11
  • FDA Inspection 704222 - 2010-11-19

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