Cambridge Isotope Laboratories, Inc.
Form 483 issued August 30, 2022 · Andover, Massachusetts
- Inspection
- Aug 15 – Aug 30, 2022
- Investigator
- Robert J. Martin
- Observations
- 1
- Pages
- 2
- FEI number
- 1000513287
In short: On August 30, 2022, FDA issued a Form 483 with 1 observation to Cambridge Isotope Laboratories, Inc. in Andover, Massachusetts (FEI 1000513287) after an inspection that ran Aug 15 – Aug 30, 2022. The investigator was Robert J. Martin. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCambridge Isotope Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cambridge Isotope Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Cambridge Isotope Laboratories, Inc.?
Robert J. Martin is named on this Form 483, for the inspection of Aug 15 – Aug 30, 2022. Each investigator has a profile showing what they cite most.
When was Cambridge Isotope Laboratories, Inc. inspected by FDA?
The inspection ran Aug 15 – Aug 30, 2022, and the Form 483 is dated August 30, 2022.
How do I get the full Form 483 for Cambridge Isotope Laboratories, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.