TOYO Pharmaceutical Co., Ltd.
Form 483 issued June 16, 2023 · Osaka, Japan
- Inspection
- Jun 12 – Jun 16, 2023
- Investigator
- Christopher R. Czajka
- Observations
- 2
- Pages
- 3
- FEI number
- 3016419927
In short: On June 16, 2023, FDA issued a Form 483 with 2 observations to TOYO Pharmaceutical Co., Ltd. in Osaka, Osaka (FEI 3016419927) after an inspection that ran Jun 12 – Jun 16, 2023. The investigator was Christopher R. Czajka. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100(b) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written production and process control procedures are…
- 02
Employees engaged in the packing of a drug product lack the training required to perform their…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmTOYO Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TOYO Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected TOYO Pharmaceutical Co., Ltd.?
Christopher R. Czajka is named on this Form 483, for the inspection of Jun 12 – Jun 16, 2023. Each investigator has a profile showing what they cite most.
When was TOYO Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jun 12 – Jun 16, 2023, and the Form 483 is dated June 16, 2023.
How do I get the full Form 483 for TOYO Pharmaceutical 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.