Amgen, Inc
Form 483 issued May 22, 2015 · Thousand Oaks, California
- Inspection
- May 4 – May 22, 2015
- Investigator
- Carla J. Lundi
- Observations
- 3
- Pages
- 2
- FEI number
- 2026154
In short: On May 22, 2015, FDA issued a Form 483 with 3 observations to Amgen, Inc in Thousand Oaks, California (FEI 2026154) after an inspection that ran May 4 – May 22, 2015. The investigator was Carla J. Lundi. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Laboratory records do not include a statement of each method used in the…
This inspection in context
Carla J. Lundi
9 documents · 2009–2021
Cites 211.160 (general requirements) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amgen, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Amgen, Inc?
Carla J. Lundi is named on this Form 483, for the inspection of May 4 – May 22, 2015. Each investigator has a profile showing what they cite most.
When was Amgen, Inc inspected by FDA?
The inspection ran May 4 – May 22, 2015, and the Form 483 is dated May 22, 2015.
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.