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Cambridge Isotope Laboratories, Inc. FDA Inspection Record

FEI 3010827078 · Inspections, Form 483s, warning letters and import refusals

Cambridge Isotope Laboratories, Inc. is an FDA-registered facility (FEI 3010827078) located in Tewksbury, MA, US. Registered operations: API MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
May 22, 2026: Voluntary Action Indicated (VAI)
Inspections on record
5 (5 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 22, 2026Voluntary Action Indicated (VAI)No citations listed
Dec 9, 2020Voluntary Action Indicated (VAI)Determination need for investigation (21 CFR 212.20(d))
Suitable for intended use (21 CFR 212.40(a))
Written specifications - containers and closures (21 CFR 212.40(b))
Adequate controls (general) (21 CFR 212.50)
Nov 7, 2017Voluntary Action Indicated (VAI)No citations listed
May 1, 2017Voluntary Action Indicated (VAI)No citations listed
Jan 7, 2015Voluntary Action Indicated (VAI)No citations listed

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Cambridge Isotope Laboratories, Inc.
Location
Tewksbury, MA (US)
Registration Expires
Dec 31, 2026
Operations
API MANUFACTURE
Source
decrs

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.