Terumo Corporation
Form 483 issued March 21, 2023 · SHOWACHO, Japan
- Inspection
- Mar 13 – Mar 21, 2023
- Investigators
- Marcellinus D. Dordunoo· Melanie W. Pishnery
- Observations
- 8
- Pages
- 10
- FEI number
- 3003752255
In short: On March 21, 2023, FDA issued a Form 483 with 8 observations to Terumo Corporation in SHOWACHO, YAMANASHI (FEI 3003752255) after an inspection that ran Mar 13 – Mar 21, 2023. The investigators were Marcellinus D. Dordunoo and Melanie W. Pishnery. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
The quality control unit lacks authority to fully investigate…
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 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 211.42(c)(10)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Terumo Corporation?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Terumo Corporation?
Marcellinus D. Dordunoo and Melanie W. Pishnery are named on this Form 483, for the inspection of Mar 13 – Mar 21, 2023. Each investigator has a profile showing what they cite most.
When was Terumo Corporation inspected by FDA?
The inspection ran Mar 13 – Mar 21, 2023, and the Form 483 is dated March 21, 2023.
How do I get the full Form 483 for Terumo Corporation?
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