Company
ItalyACS Dobfar S.p.A., Teramo, San Nicolo A Tordino, Italy – FDA Inspections
Inspection records and compliance data for ACS Dobfar S.p.A. in Teramo, San Nicolo A Tordino. 7 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 08, 2022.
Company Profile
This profile covers ACS Dobfar S.p.A. based in Teramo, San Nicolo A Tordino, Italy.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 5
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 23, 2009. Last inspected April 8, 2022.
Most cited issue areas
- Complete test data included in records2 inspections
- Computer control of master formula records2 inspections
- Environmental Monitoring System2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 8, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1203381 |
| April 13, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1123735 |
| July 21, 2017 | VAI | Human Drugs · New Drug Evaluation | 1019162 |
| January 19, 2016 | OAI | Human Drugs · Drug Quality Assurance | 955350 |
| May 23, 2014 | VAI | Human Drugs · Drug Quality Assurance | 881223 |
| March 27, 2012 | VAI | Human Drugs · Drug Quality Assurance | 777346 |
| October 23, 2009 | NAI | Human Drugs · Drug Quality Assurance | 630765 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ACS Dobfar S.p.A.
FEI Number
3006028606
Address
Nucleo Industriale Sant'Atto, Teramo, San Nicolo A Tordino, Italy
Country
Italy
ID: 8d824293-8979-42d8-822b-2373460bbf88