FDA Inspection
Advanced Accelerator Applications (Italy) S.r.l.Advanced Accelerator Applications (Italy) S.r.l. – FDA Inspection, Jun 8, 2018
Record Details
This FDA Inspection record concerns Advanced Accelerator Applications (Italy) S.r.l., with an inspection on June 8, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 387ba183-bb5b-41f7-852a-4686e4306b5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055374
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
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Other FDA inspections of Advanced Accelerator Applications (Italy) S.r.l.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Advanced Accelerator Applications (Italy) S.r.l.
- FDA Inspection 1275316 - 2023-03-03
- FDA Inspection 1128755 - 2018-10-26
- FDA Inspection 948416 - 2015-10-13
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