FDA Inspection
Ferring International Center S.A.Ferring International Center S.A. – FDA Inspection, Jan 13, 2017
Record Details
This FDA Inspection record concerns Ferring International Center S.A., with an inspection on January 13, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ba169e22-a964-4cb8-98be-8300b59eeb0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998343
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Ferring International Center S.A.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ferring International Center S.A.
- FDA Inspection 1204532 - 2023-03-29
- FDA Inspection 1100285 - 2019-08-23
- FDA Inspection 866076 - 2014-02-07
- FDA Inspection 772470 - 2012-03-15
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