Eisai Inc.
Form 483 issued April 9, 2024 · Baltimore, Maryland
- Inspection
- Apr 1 – Apr 9, 2024
- Investigators
- Azeezat M. Lawal· Pushpa S. Jayasekara· Yaharn Su
- Observations
- 3
- Pages
- 6
- FEI number
- 1000158705
In short: On April 9, 2024, FDA issued a Form 483 with 3 observations to Eisai Inc. in Baltimore, Maryland (FEI 1000158705) after an inspection that ran Apr 1 – Apr 9, 2024. The investigators were Azeezat M. Lawal, Pushpa S. Jayasekara and Yaharn Su. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine calibration of electronic equipment is not performed according to a written program designed…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Azeezat M. Lawal
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
The firmEisai Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Eisai Inc.?
Azeezat M. Lawal, Pushpa S. Jayasekara and Yaharn Su are named on this Form 483, for the inspection of Apr 1 – Apr 9, 2024. Each investigator has a profile showing what they cite most.
When was Eisai Inc. inspected by FDA?
The inspection ran Apr 1 – Apr 9, 2024, and the Form 483 is dated April 9, 2024.
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.