Eisai, Inc.
Form 483 issued November 2, 2022 · Kakamigahara, Japan
- Observations
- 1
- Pages
- 1
- FEI number
- 3004967045
In short: On November 2, 2022, FDA issued a Form 483 with 1 observation to Eisai, Inc. in Kakamigahara, Gifu (FEI 3004967045). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Questions about this 483
What did FDA find at Eisai, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Eisai, Inc. inspected by FDA?
This Form 483 is dated November 2, 2022.
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.