Suppliers / Cambridge Isotope Laboratories

Cambridge Isotope Laboratories

United States Updated 9 July 2026

Cambridge Isotope Laboratories is a contract manufacturer based in United States. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 29 January 2026 as NAI.

0
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 January 2026 NAI US FDA
  • 30 August 2022 VAI US FDA
  • 9 December 2020 VAI US FDA
  • 1 May 2017 VAI US FDA
  • 25 March 2016 VAI US FDA
  • 7 January 2015 VAI US FDA
  • 20 March 2014 VAI US FDA
  • 22 August 2011 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Andover, United States 1000513287
Tewksbury, United States 3010827078

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Cambridge Isotope Laboratories

Is Cambridge Isotope Laboratories FDA-registered?
2 sites operated by Cambridge Isotope Laboratories carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Cambridge Isotope Laboratories's last inspection go?
The most recent inspection on record closed on 29 January 2026 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Cambridge Isotope Laboratories manufacture?
2 registered sites are on record, in United States (Andover and Tewksbury). Every site is listed on this page with the register it came from.
Which regulators recognise Cambridge Isotope Laboratories's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was NAI, on 29 January 2026.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates