# FDA 483 - Ariad Pharmaceuticals - May 31, 2017

Source: https://www.globalkeysolutions.net/records/483/ariad-pharmaceuticals/8ec8d934-b117-4749-9a73-fc7d3cf87075

> FDA 483 for Ariad Pharmaceuticals on May 31, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ariad Pharmaceuticals
- Inspection Date: 2017-05-31
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of ARIAD Pharmaceuticals, Inc. in Cambridge, MA, revealed significant deficiencies in their post-market reporting processes. The firm failed to timely report serious and unexpected adverse drug experiences, including cases of neoplasm progression and death, within the required 15 calendar days. Additionally, the company did not submit follow-up NDA-Field Alert Reports within three working days for drug product quality issues, such as incorrect tablet counts in Iclusig bottles.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/ariad-pharmaceuticals/2c67b99a-1c7a-4269-b3e8-f797c72c6591)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/victoria-m-daddeo/f1832c5e-d242-4e1a-8c30-4c951c3976ea)
- [Arizona Market President](https://www.globalkeysolutions.net/people/john-p-mistler/7b2d423d-46cc-48bd-aa5a-4ae794888060)
- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.globalkeysolutions.net/companies/ariad-pharmaceuticals/b8bb8a71-2f59-4440-b7b4-0d42aee90540

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7