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FDA Inspection
•Ferring International Center S.A.•August 23, 2019

Ferring International Center S.A. – FDA Inspection, Aug 23, 2019

Record Details

This FDA Inspection record concerns Ferring International Center S.A., with an inspection on August 23, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Ferring International Center S.A.
Inspection Date
August 23, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Claire M. Minden (Investigator)
View Company Profile

ID · cac0d924-26f1-470c-a7db-f92139686827

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1100285
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.192Investigations of discrepancies, failures
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ferring International Center S.A.

4
DateClassificationOfficeProject area
March 29, 2023NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 13, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 7, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 15, 2012NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Ferring International Center S.A.
  • FDA Inspection 1204532 - 2023-03-29
  • FDA Inspection 998343 - 2017-01-13
  • FDA Inspection 866076 - 2014-02-07
  • FDA Inspection 772470 - 2012-03-15

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