FDA Inspection
Actavis Italy Spa A Socio UnicoActavis Italy Spa A Socio Unico – FDA Inspection, Oct 17, 2017
Record Details
This FDA Inspection record concerns Actavis Italy Spa A Socio Unico, with an inspection on October 17, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ea99ef27-8c9b-4975-bd8a-d8627bbb1d16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031543
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Actavis Italy Spa A Socio Unico
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2019 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| May 4, 2018 | Not classified | Office of Inspections and Investigations | |
| December 6, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Actavis Italy Spa A Socio Unico
- FDA Inspection 1119381 - 2019-05-24
- FDA Inspection 1083251 - 2019-03-15
- FDA Inspection 1050972 - 2018-05-04
- FDA Inspection 1010790 - 2016-12-06
- FDA Inspection 942841 - 2015-09-18
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