FDA Inspection
Cambridge Isotope Laboratories, Inc.Cambridge Isotope Laboratories, Inc. – FDA Inspection, Dec 9, 2020
Record Details
This FDA Inspection record concerns Cambridge Isotope Laboratories, Inc., with an inspection on December 9, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 9, 2020
- Product Type
- Drugs
View Company Profile
ID · 6bf8f50e-eecf-4456-8325-6c0b3df0ae16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1134103
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.40(b)Written specifications - containers and closures
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.40(a)Suitable for intended use
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cambridge Isotope Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2026 | Not classified | New England District Office | |
| November 7, 2017 | Not classified | New England District Office | |
| May 1, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 7, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cambridge Isotope Laboratories, Inc.
- FDA Inspection 1318354 - 2026-05-22
- FDA Inspection 1031091 - 2017-11-07
- FDA Inspection 1011952 - 2017-05-01
- FDA Inspection 909188 - 2015-01-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.