Terumo Yamaguchi Corporation
Form 483 issued March 30, 2023 · Yamaguchi, Japan
- Inspection
- Mar 30, 2023
- Investigators
- Marcellinus D. Dordunoo· Melanie W. Pishnery
- Observations
- 2
- Pages
- 2
In short: On March 30, 2023, FDA issued a Form 483 with 2 observations to Terumo Yamaguchi Corporation in Yamaguchi, Yamaguchi after an inspection that ran Mar 30, 2023. The investigators were Marcellinus D. Dordunoo and Melanie W. Pishnery. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.84(b) (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Representative samples are not taken of each shipment of each lot of components…
- 02
Backup data is not assured as complete and secure from alteration, erasure or loss through keeping…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
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 211.84(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo Yamaguchi Corporation?
FDA listed 2 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Terumo Yamaguchi Corporation?
Marcellinus D. Dordunoo and Melanie W. Pishnery are named on this Form 483, for the inspection of Mar 30, 2023. Each investigator has a profile showing what they cite most.
When was Terumo Yamaguchi Corporation inspected by FDA?
The inspection ran Mar 30, 2023, and the Form 483 is dated March 30, 2023.
How do I get the full Form 483 for Terumo Yamaguchi Corporation?
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