Company
ItalyBieffe Medital SpA, Sondalo, Italy – FDA Inspections
Inspection records and compliance data for Bieffe Medital SpA in Sondalo. 7 FDA inspections on record, 2 Form 483s, last inspected November 17, 2023.
Company Profile
This profile covers Bieffe Medital SpA based in Sondalo, Italy.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 16, 2009. Last inspected November 17, 2023.
Most cited issue areas
- CAPA verification/validation of corrective/preventive action1 inspection
- Changes to correct/prevent quality problems1 inspection
- Design history file1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1235890 |
| June 28, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1128816 |
| September 28, 2018 | Not classified | Medical Devices & Rad Health | 1126215 |
| May 29, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1057424 |
| September 22, 2015 | NAI | Human Drugs · Drug Quality Assurance | 945063 |
| August 15, 2013 | NAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 844005 |
| October 16, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 621498 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bieffe Medital SpA
FEI Number
3003591774
Address
Via Stelvio 94, Sondalo, Italy
Country
Italy
ID: a6b2f058-d687-4e04-bfd3-8b59ed1aeddd