Asahi Kasei Finechem Co., Ltd
Form 483 issued November 14, 2025 · Nobeoka, Japan
- Inspection
- Nov 10 – Nov 14, 2025
- Investigator
- Victoria Spivak
- Observations
- 1
- Pages
- 1
- FEI number
- 3002806404
In short: On November 14, 2025, FDA issued a Form 483 with 1 observation to Asahi Kasei Finechem Co., Ltd in Nobeoka, Miyazaki (FEI 3002806404) after an inspection that ran Nov 10 – Nov 14, 2025. The investigator was Victoria Spivak. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Methods used in testing must meet proper standards of accuracy and reliability as applied…
This inspection in context
Victoria Spivak
8 documents · 2023–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmAsahi Kasei Finechem Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Asahi Kasei Finechem Co., Ltd?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Asahi Kasei Finechem Co., Ltd?
Victoria Spivak is named on this Form 483, for the inspection of Nov 10 – Nov 14, 2025. Each investigator has a profile showing what they cite most.
When was Asahi Kasei Finechem Co., Ltd inspected by FDA?
The inspection ran Nov 10 – Nov 14, 2025, and the Form 483 is dated November 14, 2025.
How do I get the full Form 483 for Asahi Kasei Finechem 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.