Eisai Inc.
Form 483 issued July 22, 2016 · Baltimore, Maryland
- Inspection
- Jul 18 – Jul 22, 2016
- Investigators
- Eric L. Dong· Qin Xu
- Observations
- 4
- Pages
- 5
- FEI number
- 1000158705
In short: On July 22, 2016, FDA issued a Form 483 with 4 observations to Eisai Inc. in Baltimore, Maryland (FEI 1000158705) after an inspection that ran Jul 18 – Jul 22, 2016. The investigators were Eric L. Dong and Qin Xu. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other batches of…
- 02
Established test procedures and laboratory control…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Eric L. Dong
4 documents · 2016–2021
Cites 211.100 (written procedures; deviations) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eisai Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Eisai Inc.?
Eric L. Dong and Qin Xu are named on this Form 483, for the inspection of Jul 18 – Jul 22, 2016. Each investigator has a profile showing what they cite most.
When was Eisai Inc. inspected by FDA?
The inspection ran Jul 18 – Jul 22, 2016, and the Form 483 is dated July 22, 2016.
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.