Company
United StatesGeneral Hospital Corporation (The), Boston, MA – FDA Inspections
Inspection records and compliance data for General Hospital Corporation (The) in Boston, Massachusetts. 8 FDA inspections on record, 2 Form 483s, last inspected May 23, 2024.
Company Profile
This profile covers General Hospital Corporation (The) based in Boston, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 12, 2011. Last inspected May 23, 2024.
Most cited issue areas
- Arm preparation2 inspections
- Adverse Reaction - Investigations1 inspection
- Biological product deviation report1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 23, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1241625 |
| October 23, 2019 | NAI | Biologics · Blood and Blood Products | 1110333 |
| June 17, 2019 | Not classified | Human Drugs · Drug Quality Assurance | 1094535 |
| January 31, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1042063 |
| January 24, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 999897 |
| October 20, 2016 | VAI | Biologics · Blood and Blood Products | 992257 |
| April 28, 2014 | VAI | Biologics · Blood and Blood Products | 876646 |
| August 12, 2011 | VAI | Biologics · Blood and Blood Products | 743401 |
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
General Hospital Corporation (The)
FEI Number
1270485
Address
Blood Transfusion Service, 55 Fruit St, Boston, Massachusetts 02114, United States
Country
United States
ID: 469c1e4a-068e-47c6-82e0-601bd44c6c57