Amgen, Inc
Form 483 issued March 16, 2018 · Thousand Oaks, California
- Inspection
- Mar 12 – Mar 16, 2018
- Investigators
- Anita Narula· Bo Chi· Davinna Ligons
- Observations
- 7
- Pages
- 3
- FEI number
- 2026154
In short: On March 16, 2018, FDA issued a Form 483 with 7 observations to Amgen, Inc in Thousand Oaks, California (FEI 2026154) after an inspection that ran Mar 12 – Mar 16, 2018. The investigators were Anita Narula, Bo Chi, Davinna Ligons and Frances Namuswe. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 3 systems, led by materials.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
No investigation was conducted to identify the root cause of the working cell bank (WCB) failing…
- 02
The quality assessment of incoming raw material…
- 03
SEE Bo Chi, Ph.D., Microbiologi st REVERSE Frances Namuswe, Ph.D., Senior Staff Fellow 3/16/2018 Davinna Ligons…
- 04
The maintenance and record keeping of…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
The firmAmgen, Inc history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen, Inc?
FDA listed 7 observations on this Form 483, mostly about materials, production and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Amgen, Inc?
Anita Narula, Bo Chi, Davinna Ligons and Frances Namuswe are named on this Form 483, for the inspection of Mar 12 – Mar 16, 2018. Each investigator has a profile showing what they cite most.
When was Amgen, Inc inspected by FDA?
The inspection ran Mar 12 – Mar 16, 2018, and the Form 483 is dated March 16, 2018.
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.