Company
ItalyBioindustria Laboratorio Italiano Medicinali S.p.A, Novi Ligure, Italy – FDA Inspections
Inspection records and compliance data for Bioindustria Laboratorio Italiano Medicinali S.p.A in Novi Ligure. 5 FDA inspections on record, 1 Form 483, last inspected February 24, 2023.
Company Profile
This profile covers Bioindustria Laboratorio Italiano Medicinali S.p.A based in Novi Ligure, Italy.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 25, 2013. Last inspected February 24, 2023.
Most cited issue areas
- Batch production and Batch Control Record Requirements1 inspection
- Equipment Design, Size and Location1 inspection
- Items to cover on annual reviews1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 24, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1217681 |
| June 15, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1059528 |
| October 18, 2016 | VAI | Human Drugs · Generic Drug Evaluation | 996822 |
| March 10, 2015 | VAI | Human Drugs · Drug Quality Assurance | 924406 |
| June 25, 2013 | VAI | Human Drugs · Drug Quality Assurance | 840406 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bioindustria Laboratorio Italiano Medicinali S.p.A
FEI Number
3002717526
Address
Via De Ambrosis 2, Novi Ligure, Italy
Country
Italy
ID: 29213adb-f4cb-488a-b5f3-0ae54d911fe8