FDA Inspection
ACS Dobfar S.p.A.ACS Dobfar S.p.A. – FDA Inspection, Jan 19, 2016
Record Details
This FDA Inspection record concerns ACS Dobfar S.p.A., with an inspection on January 19, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ACS Dobfar S.p.A.
- Inspection Date
- January 19, 2016
- Product Type
- Drugs
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ID · 26802884-ae0f-4afa-94bd-6b134f9c3430
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 955350
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(5)Testing Calculations
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.194(b)Test method modification records do not include
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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 |
| May 23, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2012 | 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 881223 - 2014-05-23
- FDA Inspection 777346 - 2012-03-27
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