Amgen, Inc
Form 483 issued June 6, 2016 · Thousand Oaks, California
- Inspection
- May 31 – Jun 6, 2016
- Investigator
- Bo Chi
- Observations
- 2
- Pages
- 1
- FEI number
- 2026154
In short: On June 6, 2016, FDA issued a Form 483 with 2 observations to Amgen, Inc in Thousand Oaks, California (FEI 2026154) after an inspection that ran May 31 – Jun 6, 2016. The investigator was Bo Chi. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.42 (1×)
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
Equipment is not stored appropriately after cleaning to prevent potential microbial contamination…
This inspection in context
Bo Chi
8 documents · 2013–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen, Inc?
FDA listed 2 observations on this Form 483, mostly about 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?
Bo Chi is named on this Form 483, for the inspection of May 31 – Jun 6, 2016. Each investigator has a profile showing what they cite most.
When was Amgen, Inc inspected by FDA?
The inspection ran May 31 – Jun 6, 2016, and the Form 483 is dated June 6, 2016.
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.