Company
ItalyBayer Healthcare Manufacturing Srl, Garbagnate Milanese, Italy – FDA Inspections
Inspection records and compliance data for Bayer Healthcare Manufacturing Srl in Garbagnate Milanese. 5 FDA inspections on record, last inspected July 20, 2023.
Company Profile
This profile covers Bayer Healthcare Manufacturing Srl based in Garbagnate Milanese, Italy.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected April 3, 2009. Last inspected July 20, 2023.
Most cited issue areas
- Complete test data included in records1 inspection
- Sample identification and other information1 inspection
- Written record of investigation incomplete1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1270855 |
| April 19, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1133402 |
| October 16, 2015 | NAI | Human Drugs · Drug Quality Assurance | 947913 |
| March 15, 2013 | NAI | Human Drugs · Drug Quality Assurance | 826683 |
| April 3, 2009 | VAI | Human Drugs · Drug Quality Assurance | 583049 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bayer Healthcare Manufacturing Srl
FEI Number
3002806461
Address
Via Delle Groane 126, Garbagnate Milanese, Italy
Country
Italy
ID: 87d94a4f-d40c-44fb-b843-233d2311794f