ARIAD Pharmaceuticals
Form 483 issued May 31, 2017 · Cambridge, Massachusetts
- Inspection
- May 22 – May 31, 2017
- Investigators
- Erik W. Koester· John P. Mistler· Victoria M. Daddeo
- Observations
- 2
- Pages
- 3
- FEI number
- 1000513233
In short: On May 31, 2017, FDA issued a Form 483 with 2 observations to ARIAD Pharmaceuticals in Cambridge, Massachusetts (FEI 1000513233) after an inspection that ran May 22 – May 31, 2017. The investigators were Erik W. Koester, John P. Mistler and Victoria M. Daddeo. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmARIAD Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ARIAD Pharmaceuticals?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected ARIAD Pharmaceuticals?
Erik W. Koester, John P. Mistler and Victoria M. Daddeo are named on this Form 483, for the inspection of May 22 – May 31, 2017. Each investigator has a profile showing what they cite most.
When was ARIAD Pharmaceuticals inspected by FDA?
The inspection ran May 22 – May 31, 2017, and the Form 483 is dated May 31, 2017.
How do I get the full Form 483 for ARIAD Pharmaceuticals?
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.