Amgen, Inc
Form 483 issued February 17, 2017 · Thousand Oaks, California
- Inspection
- Feb 6 – Feb 17, 2017
- Investigators
- Mohsen Rajabi Abhari· Stanley Au
- Observations
- 1
- Pages
- 3
- FEI number
- 2026154
In short: On February 17, 2017, FDA issued a Form 483 with 1 observation to Amgen, Inc in Thousand Oaks, California (FEI 2026154) after an inspection that ran Feb 6 – Feb 17, 2017. The investigators were Mohsen Rajabi Abhari and Stanley Au. Most observations concern clinical (BIMO).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
All recommended validation parameters were not evaluated in the ) method…
This inspection in context
Questions about this 483
What did FDA find at Amgen, Inc?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected Amgen, Inc?
Mohsen Rajabi Abhari and Stanley Au are named on this Form 483, for the inspection of Feb 6 – Feb 17, 2017. Each investigator has a profile showing what they cite most.
When was Amgen, Inc inspected by FDA?
The inspection ran Feb 6 – Feb 17, 2017, and the Form 483 is dated February 17, 2017.
How do I get the full Form 483 for Amgen, 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.