Company
ItalyAdare Pharmaceuticals Srl, Pessano Con Bornago, Italy – FDA Inspections
Inspection records and compliance data for Adare Pharmaceuticals Srl in Pessano Con Bornago. 6 FDA inspections on record, 1 Form 483, last inspected October 28, 2022.
Company Profile
This profile covers Adare Pharmaceuticals Srl based in Pessano Con Bornago, Italy.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 9, 2009. Last inspected October 28, 2022.
Most cited issue areas
- Computer control of master formula records1 inspection
- Drug product sample1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1204801 |
| April 13, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1098299 |
| February 24, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1006241 |
| May 30, 2014 | VAI | Human Drugs · Drug Quality Assurance | 883317 |
| July 19, 2012 | NAI | Human Drugs · Drug Quality Assurance | 793805 |
| October 9, 2009 | VAI | Human Drugs · Drug Quality Assurance | 622477 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Adare Pharmaceuticals Srl
FEI Number
1000573478
Address
Via Martin Luther King 13, Pessano Con Bornago, Italy
Country
Italy
ID: d3b29a2a-343c-45ab-9ab7-0159306f853d