Fujimoto Chemicals CO., Ltd.
Form 483 issued February 7, 2024 · Amagasaki, Japan
- Inspection
- Aug 25, 2023 – Feb 7, 2024
- Investigator
- Dennis Cantellops
- Observations
- 3
- Pages
- 3
- FEI number
- 3002806358
In short: On February 7, 2024, FDA issued a Form 483 with 3 observations to Fujimoto Chemicals CO., Ltd. in Amagasaki, Hyogo (FEI 3002806358) after an inspection that ran Aug 25, 2023 – Feb 7, 2024. The investigator was Dennis Cantellops. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Laboratory Control System) Laboratory controls do not include the establishment of scientifically sound and appropriate test…
- 02
(Material System) There was a failure to handle and store components at all times in a…
- 03
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmFujimoto Chemicals CO., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fujimoto Chemicals CO., Ltd.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Fujimoto Chemicals CO., Ltd.?
Dennis Cantellops is named on this Form 483, for the inspection of Aug 25, 2023 – Feb 7, 2024. Each investigator has a profile showing what they cite most.
When was Fujimoto Chemicals CO., Ltd. inspected by FDA?
The inspection ran Aug 25, 2023 – Feb 7, 2024, and the Form 483 is dated February 7, 2024.
How do I get the full Form 483 for Fujimoto Chemicals CO., Ltd.?
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.