Amgen, Inc
Form 483 issued December 13, 2019 · Thousand Oaks, California
- Inspection
- Dec 9 – Dec 13, 2019
- Investigator
- Roger F. Zabinski
- Observations
- 1
- Pages
- 1
- FEI number
- 2026154
In short: On December 13, 2019, FDA issued a Form 483 with 1 observation to Amgen, Inc in Thousand Oaks, California (FEI 2026154) after an inspection that ran Dec 9 – Dec 13, 2019. The investigator was Roger F. Zabinski. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b)(6) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) 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(b)(6)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen, Inc?
FDA listed 1 observation 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?
Roger F. Zabinski is named on this Form 483, for the inspection of Dec 9 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was Amgen, Inc inspected by FDA?
The inspection ran Dec 9 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
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.