Amgen, Inc
Form 483 issued May 16, 2017 · Thousand Oaks, California
- Inspection
- May 8 – May 16, 2017
- Investigators
- Jee Y. Chung· Laura Fontan· Sarah Arden
- Observations
- 5
- Pages
- 2
- FEI number
- 2026154
In short: On May 16, 2017, FDA issued a Form 483 with 5 observations to Amgen, Inc in Thousand Oaks, California (FEI 2026154) after an inspection that ran May 8 – May 16, 2017. The investigators were Jee Y. Chung, Laura Fontan and Sarah Arden. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The information provided does not support that existing procedural controls and process containment are adequate to…
- 02
Multiple validated product pool hold times were exceeded in the manufacture of (b) (4) drug substance…
- 03
Operating procedures and validation process for the Building…
- 04
The information provided does not adequately support using (b) (4) for all products produced…
This inspection in context
Jee Y. Chung
5 documents · 2013–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen, Inc?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Amgen, Inc?
Jee Y. Chung, Laura Fontan and Sarah Arden are named on this Form 483, for the inspection of May 8 – May 16, 2017. Each investigator has a profile showing what they cite most.
When was Amgen, Inc inspected by FDA?
The inspection ran May 8 – May 16, 2017, and the Form 483 is dated May 16, 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.