Eisai Co., Ltd.
Form 483 issued November 18, 2022 · Kamisu-shi, Japan
- Inspection
- Nov 14 – Nov 18, 2022
- Investigator
- Rumany C. Penn
- Observations
- 4
- Pages
- 2
- FEI number
- 3002806886
In short: On November 18, 2022, FDA issued a Form 483 with 4 observations to Eisai Co., Ltd. in Kamisu-shi, Ibaraki (FEI 3002806886) after an inspection that ran Nov 14 – Nov 18, 2022. The investigator was Rumany C. Penn. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes are instituted…
- 02
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 03
Strict control is not exercised over labeling issued for use in…
- 04
API, intermediates, and raw materials use for production are not stored under appropriate conditions of temperature…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmEisai Co., Ltd. history
The site's inspection history, in date order.
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 Eisai Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Eisai Co., Ltd.?
Rumany C. Penn is named on this Form 483, for the inspection of Nov 14 – Nov 18, 2022. Each investigator has a profile showing what they cite most.
When was Eisai Co., Ltd. inspected by FDA?
The inspection ran Nov 14 – Nov 18, 2022, and the Form 483 is dated November 18, 2022.
How do I get the full Form 483 for Eisai Co., Ltd.?
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.