Fujimoto Chemicals Co., Ltd.
Form 483 issued May 12, 2023 · Izumiotsu, Japan
- Inspection
- May 8 – May 12, 2023
- Investigator
- Saundrea A. Munroe
- Observations
- 1
- Pages
- 3
- FEI number
- 3009975775
In short: On May 12, 2023, FDA issued a Form 483 with 1 observation to Fujimoto Chemicals Co., Ltd. in Izumiotsu, Osaka (FEI 3009975775) after an inspection that ran May 8 – May 12, 2023. The investigator was Saundrea A. Munroe. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmFujimoto Chemicals Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fujimoto Chemicals Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about materials. 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 Fujimoto Chemicals Co., Ltd.?
Saundrea A. Munroe is named on this Form 483, for the inspection of May 8 – May 12, 2023. Each investigator has a profile showing what they cite most.
When was Fujimoto Chemicals Co., Ltd. inspected by FDA?
The inspection ran May 8 – May 12, 2023, and the Form 483 is dated May 12, 2023.
How do I get the full Form 483 for Fujimoto Chemicals Co., Ltd.?
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