Company
United StatesCambridge Isotope Laboratories, Inc., Tewksbury, MA – FDA Inspections
Inspection records and compliance data for Cambridge Isotope Laboratories, Inc. in Tewksbury, Massachusetts. 5 FDA inspections on record, 3 Form 483s, last inspected May 22, 2026.
Company Profile
This profile covers Cambridge Isotope Laboratories, Inc. based in Tewksbury, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected January 7, 2015. Last inspected May 22, 2026.
Most cited issue areas
- Adequate controls (general)1 inspection
- Determination need for investigation1 inspection
- Suitable for intended use1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2026 | Not classified | Human Drugs | 1318354 |
| December 9, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1134103 |
| November 7, 2017 | Not classified | Human Drugs | 1031091 |
| May 1, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1011952 |
| January 7, 2015 | VAI | Human Drugs · Drug Quality Assurance | 909188 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Cambridge Isotope Laboratories, Inc.
FEI Number
3010827078
Address
3 Highwood Dr, Tewksbury, Massachusetts 01876, United States
Country
United States
ID: 86432a1b-751d-40d3-bf8a-9624c97f584b