Terumo Yamaguchi Corporation
Form 483 issued February 19, 2020 · SAYAMA, Japan
- Inspection
- Feb 13 – Feb 19, 2020
- Investigators
- Virginia A. Carroll· Wayne Seifert
- Observations
- 10
- Pages
- 4
- FEI number
- 3013611763
In short: On February 19, 2020, FDA issued a Form 483 with 10 observations to Terumo Yamaguchi Corporation in SAYAMA, YAMAGUCHI (FEI 3013611763) after an inspection that ran Feb 13 – Feb 19, 2020. The investigators were Virginia A. Carroll and Wayne Seifert. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Facilities & equipment and quality system account for 7 of 10 observations.
Most cited: 21 CFR 211.67 (3×) · 211.25 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for maintaining equipment used to…
- 02
Analysts are not adequately qualified to conduct inspections of media-filled units for the presence of contamination…
- 03
Procedures designed to prevent microbiological contamination of drug product purporting to be sterile do not include…
- 04
The environmental monitoring program for aseptic processing areas…
This inspection in context
Virginia A. Carroll
5 documents · 2018–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmTerumo Yamaguchi 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo Yamaguchi Corporation?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Terumo Yamaguchi Corporation?
Virginia A. Carroll and Wayne Seifert are named on this Form 483, for the inspection of Feb 13 – Feb 19, 2020. Each investigator has a profile showing what they cite most.
When was Terumo Yamaguchi Corporation inspected by FDA?
The inspection ran Feb 13 – Feb 19, 2020, and the Form 483 is dated February 19, 2020.
How do I get the full Form 483 for Terumo Yamaguchi 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.