FDA Inspection
Cosmo S.p.A.Cosmo S.p.A. – FDA Inspection, Nov 10, 2017
Record Details
This FDA Inspection record concerns Cosmo S.p.A., with an inspection on November 10, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
- Person
- Dien N. Nguyen (Issuing Officer)
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ID · e115957f-c45b-4146-81c1-f9d16ece2f02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031678
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.110(a)(3)Mixing adequacy
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Other FDA inspections of Cosmo S.p.A.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 11, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2019 | Not classified | Office of Inspections and Investigations | |
| February 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 8, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosmo S.p.A.
- FDA Inspection 1204687 - 2022-11-11
- FDA Inspection 1108214 - 2019-09-17
- FDA Inspection 1087571 - 2018-02-02
- FDA Inspection 937601 - 2015-07-08
- FDA Inspection 843032 - 2013-07-18
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