Company
United StatesNew England Cryogenic Center, Inc., Marlborough, MA – FDA Inspections
Inspection records and compliance data for New England Cryogenic Center, Inc. in Marlborough, Massachusetts. 9 FDA inspections on record, last inspected August 13, 2025.
Company Profile
This profile covers New England Cryogenic Center, Inc. based in Marlborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 2
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 14, 2011. Last inspected August 13, 2025.
Most cited issue areas
- Deviations--Investigation, documenting, trending1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Procedures to meet core CTGP1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 13, 2025 | Not classified | Biologics | 1281063 |
| November 3, 2021 | NAI | Biologics · Blood and Blood Products | 1158602 |
| November 5, 2018 | NAI | Biologics · Blood and Blood Products | 1074514 |
| December 7, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 994774 |
| September 10, 2014 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 895389 |
| February 13, 2013 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 820144 |
| March 6, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 767433 |
| March 16, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 717872 |
| February 14, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 712615 |
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
New England Cryogenic Center, Inc.
FEI Number
3002733251
Address
500 Donald Lynch Blvd, Marlborough, Massachusetts 01752, United States
Country
United States
ID: fe4950be-4eb0-4064-bde4-a33ce62f12f1