In short: On December 13, 2024, FDA issued a Form 483 with 6 observations to Terumo Corporation in SHOWACHO, YAMANASHI (FEI 3003752255) after an inspection that ran Dec 4 – Dec 13, 2024. The investigators were Ruo H. Xu and Zhong Li. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Your firm has not established adequate procedural controls to protect the electronic data acquisition systems used…
This inspection in context
Ruo H. Xu
4 documents · 2017–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmTerumo Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo Corporation?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Terumo Corporation?
Ruo H. Xu and Zhong Li are named on this Form 483, for the inspection of Dec 4 – Dec 13, 2024. Each investigator has a profile showing what they cite most.
When was Terumo Corporation inspected by FDA?
The inspection ran Dec 4 – Dec 13, 2024, and the Form 483 is dated December 13, 2024.
How do I get the full Form 483 for Terumo Corporation?
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.