FDA Inspection
Actavis Italy Spa A Socio UnicoActavis Italy Spa A Socio Unico – FDA Inspection, Mar 15, 2019
Record Details
This FDA Inspection record concerns Actavis Italy Spa A Socio Unico, with an inspection on March 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f716a472-60dc-427f-93c5-81d95b02fbb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083251
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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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 |
| May 4, 2018 | Not classified | Office of Inspections and Investigations | |
| October 17, 2017 | VAI | Office of Inspections and Investigations | New Drug Evaluation |
| 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 1050972 - 2018-05-04
- FDA Inspection 1031543 - 2017-10-17
- FDA Inspection 1010790 - 2016-12-06
- FDA Inspection 942841 - 2015-09-18
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