Eisai Inc.
FDA inspection history in Baltimore, Maryland, 2016 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Baltimore, Maryland.
- 2016The longest 483 on file: 4 observations over 5 pages at Baltimore, Maryland.
- 2024One Form 483, at Baltimore, Maryland.
Cited most
Across all Eisai observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.194(a)Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Eisai file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Baltimore, Maryland
Two Form 483s · 2016 to 2024 · 7 observations
Latest: Form 483, Apr 9, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-09 | 483 Form 483 | Baltimore, Maryland | 3 | $99 |
| 2016-07-22 | 483 Form 483 | Baltimore, Maryland | 4 | $99 |
Investigators on these documents
Azeezat M. Lawal (1)Eric L. Dong (1)Pushpa S. Jayasekara (1)Qin Xu (1)Yaharn Su (1)
FEI number 1000158705 · most recent document Apr 9, 2024
About Eisai Inc.
How many FDA Form 483s has Eisai Inc. received?
FDA Intel has 2 Form 483s on file for Eisai Inc.; the most recent is dated Apr 9, 2024.
When was Eisai Inc. last inspected by FDA?
The most recent FDA inspection document on file for Eisai Inc. is a Form 483 dated Apr 9, 2024, for the site in Baltimore, Maryland.
What did FDA cite at Eisai Inc.?
The regulations cited most in the observations on file for Eisai Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.160(a) (General requirements), 1 time.