Cambridge Isotope Laboratories, Inc.
Form 483 issued May 1, 2017 · Tewksbury, Massachusetts
- Inspection
- Apr 12 – May 1, 2017
- Investigators
- John P. Mistler· Sean R. Marcsisin
- Observations
- 4
- Pages
- 7
- FEI number
- 3010827078
In short: On May 1, 2017, FDA issued a Form 483 with 4 observations to Cambridge Isotope Laboratories, Inc. in Tewksbury, Massachusetts (FEI 3010827078) after an inspection that ran Apr 12 – May 1, 2017. The investigators were John P. Mistler and Sean R. Marcsisin. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures).
At a glance
Materials and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm utilized P(4) ^ manufacturer’s 24 month shelflife for the purification of active pharmaceutical ingredient…
- 02
The Quality Unit failed to perform adequate and timely investigations and/or measures into quality related events…
- 03
The Quality Unit failed to sample and/or test critical raw material used in the manufacturing of…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
John P. Mistler
15 documents · 2015–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.87
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, mostly about materials, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Cambridge Isotope Laboratories, Inc.?
John P. Mistler and Sean R. Marcsisin are named on this Form 483, for the inspection of Apr 12 – May 1, 2017. Each investigator has a profile showing what they cite most.
When was Cambridge Isotope Laboratories, Inc. inspected by FDA?
The inspection ran Apr 12 – May 1, 2017, and the Form 483 is dated May 1, 2017.
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.