Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho
Form 483 issued August 7, 2025 · Suzuka, Japan
- Inspection
- Aug 3 – Aug 7, 2025
- Investigator
- Tekalign Wondimu
- Observations
- 3
- Pages
- 2
- FEI number
- 3003028650
In short: On August 7, 2025, FDA issued a Form 483 with 3 observations to Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho in Suzuka, MIE (FEI 3003028650) after an inspection that ran Aug 3 – Aug 7, 2025. The investigator was Tekalign Wondimu. Most observations concern materials and production.
At a glance
Materials and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The number of containers to be sampled is not…
- 02
Procedures designed to prevent objectionable microorganisms in ding products not required to be sterile are…
- 03
Failure to maintain a backup file of data entered into the…
This inspection in context
Tekalign Wondimu
12 documents · 2021–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Virginia.
The firmSumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho 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 Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho?
FDA listed 3 observations on this Form 483, mostly about materials, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho?
Tekalign Wondimu is named on this Form 483, for the inspection of Aug 3 – Aug 7, 2025. Each investigator has a profile showing what they cite most.
When was Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho inspected by FDA?
The inspection ran Aug 3 – Aug 7, 2025, and the Form 483 is dated August 7, 2025.
How do I get the full Form 483 for Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho?
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.