Company
United StatesSteward St. Elizabeth's Medical Center, Brighton, MA – FDA Inspections
Inspection records and compliance data for Steward St. Elizabeth's Medical Center in Brighton, Massachusetts. 6 FDA inspections on record, 1 Form 483, last inspected October 03, 2019.
Company Profile
This profile covers Steward St. Elizabeth's Medical Center based in Brighton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected July 23, 2009. Last inspected October 3, 2019.
Most cited issue areas
- Batch production and Batch Control Record Requirements1 inspection
- Equipment observed, standardized, calibrated1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 3, 2019 | NAI | Biologics · Blood and Blood Products | 1109119 |
| January 31, 2017 | VAI | Biologics · Blood and Blood Products | 1000063 |
| November 20, 2014 | NAI | Biologics · Blood and Blood Products | 905496 |
| March 27, 2013 | NAI | Biologics · Blood and Blood Products | 824526 |
| April 22, 2011 | VAI | Biologics · Blood and Blood Products | 721585 |
| July 23, 2009 | NAI | Biologics · Blood and Blood Products | 598777 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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SYNLOGIC
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Raymond T. Chung, M.D.
Company Information
Name
Steward St. Elizabeth's Medical Center
FEI Number
1271560
Address
736 Cambridge St, Brighton, Massachusetts 02135, United States
Country
United States
ID: 15d38b33-89b6-453f-a0a6-b40208857341