FDA Inspection
Avara Liscate Pharmaceutical Services SPAAvara Liscate Pharmaceutical Services SPA – FDA Inspection, Sep 20, 2019
Record Details
This FDA Inspection record concerns Avara Liscate Pharmaceutical Services SPA, with an inspection on September 20, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f832bcef-afb3-42ed-867e-8908fd2b34a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102380
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Avara Liscate Pharmaceutical Services SPA
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 13, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Avara Liscate Pharmaceutical Services SPA
- FDA Inspection 1244256 - 2023-06-09
- FDA Inspection 1192062 - 2022-12-06
- FDA Inspection 1000021 - 2016-11-22
- FDA Inspection 881210 - 2014-05-13
- FDA Inspection 754834 - 2011-11-09
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