Company
United StatesNew England Donor Services, Waltham, MA – FDA Inspections
Inspection records and compliance data for New England Donor Services in Waltham, Massachusetts. 5 FDA inspections on record, last inspected January 28, 2025.
Company Profile
This profile covers New England Donor Services based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected October 15, 2010. Last inspected January 28, 2025.
Most cited issue areas
- Aseptic processing---cleaning, disinfecting1 inspection
- Description of methods, schedule1 inspection
- Procedures for cleaning, sanitation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 28, 2025 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1261185 |
| March 22, 2019 | NAI | Biologics · Blood and Blood Products | 1088409 |
| August 25, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 983543 |
| August 1, 2013 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 844021 |
| October 15, 2010 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 696247 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
New England Donor Services
FEI Number
3002920128
Address
60 1st Ave, Waltham, Massachusetts 02451, United States
Country
United States
ID: 4f9c904c-ddd5-46ff-a31a-fcdf8799fec8