Company
United StatesMontefiore New Rochelle, New Rochelle, NY – FDA Inspections
Inspection records and compliance data for Montefiore New Rochelle in New Rochelle, New York. 3 FDA inspections on record, last inspected February 18, 2014.
Company Profile
This profile covers Montefiore New Rochelle based in New Rochelle, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 10, 2009. Last inspected February 18, 2014.
Most cited issue areas
- Thorough investigations2 inspections
- Establish, maintain and follow manufacturing SOPs1 inspection
- Legibility and indelibility1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 18, 2014 | NAI | Biologics · Blood and Blood Products | 866376 |
| August 15, 2012 | VAI | Biologics · Blood and Blood Products | 794496 |
| November 10, 2009 | VAI | Biologics · Blood and Blood Products | 622870 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Montefiore New Rochelle
FEI Number
2473606
Address
16 Guion Pl, New Rochelle, New York 10801, United States
Country
United States
ID: 4b329b6a-59c1-45cd-aeeb-b6aef79b9db7