FDA Inspection
Alfasigma S.p.A.Alfasigma S.p.A. – FDA Inspection, Nov 10, 2015
Record Details
This FDA Inspection record concerns Alfasigma S.p.A., with an inspection on November 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Alfasigma S.p.A.
- Inspection Date
- November 10, 2015
- Product Type
- Drugs
View Company Profile
ID · ffb26e54-29b8-46a8-9007-e6d4a882316c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951583
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Alfasigma S.p.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 28, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 30, 2017 | Not classified | Office of Inspections and Investigations | |
| September 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alfasigma S.p.A.
- FDA Inspection 1293602 - 2024-01-26
- FDA Inspection 1202245 - 2021-05-28
- FDA Inspection 1056604 - 2018-06-21
- FDA Inspection 1023437 - 2017-06-30
- FDA Inspection 748680 - 2011-09-16
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