Ishihara Sangyo Kaisha, Ltd.
Form 483 issued September 9, 2022 · Yokkaichi, Japan
- Inspection
- Sep 9, 2022
- Investigator
- Santiago Gallardo Johnson
- Observations
- 2
- Pages
- 1
- FEI number
- 3002807309
In short: On September 9, 2022, FDA issued a Form 483 with 2 observations to Ishihara Sangyo Kaisha, Ltd. in Yokkaichi, Mie (FEI 3002807309) after an inspection that ran Sep 9, 2022. The investigator was Santiago Gallardo Johnson. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to document and investigate any…
- 02
Failure to follow establish…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmIshihara Sangyo Kaisha, 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 Ishihara Sangyo Kaisha, Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. 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 Ishihara Sangyo Kaisha, Ltd.?
Santiago Gallardo Johnson is named on this Form 483, for the inspection of Sep 9, 2022. Each investigator has a profile showing what they cite most.
When was Ishihara Sangyo Kaisha, Ltd. inspected by FDA?
The inspection ran Sep 9, 2022, and the Form 483 is dated September 9, 2022.
How do I get the full Form 483 for Ishihara Sangyo Kaisha, 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.