Eisai, Inc.
Form 483 issued June 28, 2019 · Kakamigahara, Japan
- Inspection
- Jun 24 – Jun 28, 2019
- Observations
- 2
- Pages
- 1
- FEI number
- 3004967045
In short: On June 28, 2019, FDA issued a Form 483 with 2 observations to Eisai, Inc. in Kakamigahara, Gifu (FEI 3004967045) after an inspection that ran Jun 24 – Jun 28, 2019. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.182 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not documented at…
- 02
Records are not kept for the maintenance…
This inspection in context
Questions about this 483
What did FDA find at Eisai, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Eisai, Inc. inspected by FDA?
The inspection ran Jun 24 – Jun 28, 2019, and the Form 483 is dated June 28, 2019.
How do I get the full Form 483 for Eisai, 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.