Cambridge Isotope Laboratories, Inc.
Form 483 issued December 9, 2020 · Tewksbury, Massachusetts
- Inspection
- Aug 31 – Dec 9, 2020
- Investigator
- Robert J. Martin
- Observations
- 4
- Pages
- 4
- FEI number
- 3010827078
In short: On December 9, 2020, FDA issued a Form 483 with 4 observations to Cambridge Isotope Laboratories, Inc. in Tewksbury, Massachusetts (FEI 3010827078) after an inspection that ran Aug 31 – Dec 9, 2020. The investigator was Robert J. Martin. The most-cited regulation is 21 CFR 212.40 (how must I control the components I use to produce PET drugs and the containers and closures I package them in?).
What FDA observed
Preview: the opening words of each observation- 01
When errors occurred or a production batch or any component of the batch, failed to meet…
- 0221 CFR 212.40(b)
You did not establish appropriate written specifications for the quality of drug…
- 03
Your firm lacks adequate production and process controls to ensure the consistent production of a PET…
- 0421 CFR 212.40(a)
Your written procedures are not adequate to ensure that the containers and closures are suitable…
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 212.20(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cambridge Isotope Laboratories, Inc.?
FDA listed 4 observations on this Form 483. The most-cited regulation is 21 CFR 212.40 (how must I control the components I use to produce PET drugs and the containers and closures I package them in?). 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 31 – Dec 9, 2020. Each investigator has a profile showing what they cite most.
When was Cambridge Isotope Laboratories, Inc. inspected by FDA?
The inspection ran Aug 31 – Dec 9, 2020, and the Form 483 is dated December 9, 2020.
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.