FDA Inspection
Advanced Accelerator Applications (Italy) srlFDA Inspection 1100975 - Advanced Accelerator Applications (Italy) srl - September 03, 2019
Record Details
This FDA Inspection record concerns Advanced Accelerator Applications (Italy) srl, with an inspection on September 3, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 3, 2019
- Product Type
- Drugs
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ID · efa13b63-8326-43dc-a295-feebdc42dfa5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100975
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Advanced Accelerator Applications (Italy) srl
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 5, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Advanced Accelerator Applications (Italy) srl
- FDA Inspection 1274974 - 2023-10-13
- FDA Inspection 985534 - 2016-08-05
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