Eisai, Inc.
Form 483 issued October 27, 2023 · Kakamigahara, Japan
- Inspection
- Oct 23 – Oct 27, 2023
- Investigators
- Ankur C. Patel· Bijoy Panicker
- Observations
- 2
- Pages
- 2
- FEI number
- 3004967045
In short: On October 27, 2023, FDA issued a Form 483 with 2 observations to Eisai, Inc. in Kakamigahara, Gifu (FEI 3004967045) after an inspection that ran Oct 23 – Oct 27, 2023. The investigators were Ankur C. Patel and Bijoy Panicker. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.142(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Dmg products are not stored under appropriate conditions of hmnidity so that their identity, strength, quality…
This inspection in context
Ankur C. Patel
9 documents · 2021–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmEisai, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eisai, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Eisai, Inc.?
Ankur C. Patel and Bijoy Panicker are named on this Form 483, for the inspection of Oct 23 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Eisai, Inc. inspected by FDA?
The inspection ran Oct 23 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
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.