Cambridge Isotope Laboratories, Inc.
Form 483 issued March 25, 2016 · Andover, Massachusetts
- Inspection
- Mar 11 – Mar 25, 2016
- Investigator
- Stacey S. Degarmo
- Observations
- 3
- Pages
- 2
- FEI number
- 1000513287
In short: On March 25, 2016, FDA issued a Form 483 with 3 observations to Cambridge Isotope Laboratories, Inc. in Andover, Massachusetts (FEI 1000513287) after an inspection that ran Mar 11 – Mar 25, 2016. The investigator was Stacey S. Degarmo. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit failed to adequately investigate and/or provide oversight and follow up for events that…
- 02
The firm lacks appropriate efforts to assure the quality of the packing of the purification column…
- 03
The valves and (b) (4) cylinders used in the synthesis ofC-13 UREA are not covered by…
This inspection in context
Stacey S. Degarmo
10 documents · 2010–2016
Cites 211.42 (design and construction features) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cambridge Isotope Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Cambridge Isotope Laboratories, Inc.?
Stacey S. Degarmo is named on this Form 483, for the inspection of Mar 11 – Mar 25, 2016. Each investigator has a profile showing what they cite most.
When was Cambridge Isotope Laboratories, Inc. inspected by FDA?
The inspection ran Mar 11 – Mar 25, 2016, and the Form 483 is dated March 25, 2016.
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.