FDA Inspection
ACS Dobfar S.p.A.ACS Dobfar S.p.A. – FDA Inspection, Mar 27, 2012
Record Details
This FDA Inspection record concerns ACS Dobfar S.p.A., with an inspection on March 27, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ACS Dobfar S.p.A.
- Inspection Date
- March 27, 2012
- Product Type
- Drugs
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ID · f9cc5678-8659-48f5-96b4-e42dc711e3ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777346
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.46(a)Adequate ventilation not provided
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of ACS Dobfar S.p.A.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2017 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| January 19, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ACS Dobfar S.p.A.
- FDA Inspection 1203381 - 2022-04-08
- FDA Inspection 1123735 - 2018-04-13
- FDA Inspection 1019162 - 2017-07-21
- FDA Inspection 955350 - 2016-01-19
- FDA Inspection 881223 - 2014-05-23
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