Amgen, Inc
Form 483 issued February 6, 2024 · Thousand Oaks, California
- Inspection
- Jan 29 – Feb 6, 2024
- Investigators
- Della Shin· Esther C. Broner· Zhong Li
- Observations
- 5
- Pages
- 5
- FEI number
- 2026154
In short: On February 6, 2024, FDA issued a Form 483 with 5 observations to Amgen, Inc in Thousand Oaks, California (FEI 2026154) after an inspection that ran Jan 29 – Feb 6, 2024. The investigators were Della Shin, Esther C. Broner and Zhong Li. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Your firm’s documentation practices do not adequately ensure accuracy and completeness of data to support the…
- 03
There is a lack of assurance that your drug product manufacturing operations in (b) (4) are…
- 04
Your firm has not established adequate procedural controls to protect the electronic data acquisition and manufacturing…
This inspection in context
Della Shin
3 documents · 2024–2025
Cites 211.113 (control of microbiological contamination) 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 211.68
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 facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Amgen, Inc?
Della Shin, Esther C. Broner and Zhong Li are named on this Form 483, for the inspection of Jan 29 – Feb 6, 2024. Each investigator has a profile showing what they cite most.
When was Amgen, Inc inspected by FDA?
The inspection ran Jan 29 – Feb 6, 2024, and the Form 483 is dated February 6, 2024.
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.