Sakai Chemical Industry Co., Ltd.
Form 483 issued November 17, 2023 · IWAKI, Japan
- Inspection
- Nov 13 – Nov 17, 2023
- Investigator
- Annet R. Rajan
- Observations
- 1
- Pages
- 2
- FEI number
- 3005889724
In short: On November 17, 2023, FDA issued a Form 483 with 1 observation to Sakai Chemical Industry Co., Ltd. in IWAKI, FUKUSHIMA (FEI 3005889724) after an inspection that ran Nov 13 – Nov 17, 2023. The investigator was Annet R. Rajan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit failed to adequately investigate laboratory errors and out-of-specification results and/or justify…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmSakai Chemical Industry Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sakai Chemical Industry Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sakai Chemical Industry Co., Ltd.?
Annet R. Rajan is named on this Form 483, for the inspection of Nov 13 – Nov 17, 2023. Each investigator has a profile showing what they cite most.
When was Sakai Chemical Industry Co., Ltd. inspected by FDA?
The inspection ran Nov 13 – Nov 17, 2023, and the Form 483 is dated November 17, 2023.
How do I get the full Form 483 for Sakai Chemical Industry 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.