FDA Inspection
ACS Dobfar S.p.A.ACS Dobfar S.p.A. – FDA Inspection, Jun 19, 2018
Record Details
This FDA Inspection record concerns ACS Dobfar S.p.A., with an inspection on June 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 76584a80-7e4c-4d59-89b9-7be4a0e1a2f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056132
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of ACS Dobfar S.p.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 8, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ACS Dobfar S.p.A.
- FDA Inspection 1273719 - 2023-10-27
- FDA Inspection 1122752 - 2019-04-19
- FDA Inspection 973195 - 2016-05-20
- FDA Inspection 873439 - 2014-03-18
- FDA Inspection 751609 - 2011-07-08
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