Taenaka Kogyo Co., Ltd. 452 Oshiba
Form 483 issued April 12, 2024 · Mobara, Japan
- Inspection
- Apr 8 – Apr 12, 2024
- Investigator
- Christopher R. Czajka
- Observations
- 2
- Pages
- 3
- FEI number
- 3003282619
In short: On April 12, 2024, FDA issued a Form 483 with 2 observations to Taenaka Kogyo Co., Ltd. 452 Oshiba in Mobara, Japan (FEI 3003282619) after an inspection that ran Apr 8 – Apr 12, 2024. The investigator was Christopher R. Czajka. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.25 (1×) · 211.46 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Training is not regularly conducted by qualified individuals, does not cover the particular operations that employees…
- 02
Ventilation systems, including equipment for control of air pressure, are not adequately designed and constructed to…
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 firmTaenaka Kogyo Co., Ltd. 452 Oshiba history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Taenaka Kogyo Co., Ltd. 452 Oshiba?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Taenaka Kogyo Co., Ltd. 452 Oshiba?
Christopher R. Czajka is named on this Form 483, for the inspection of Apr 8 – Apr 12, 2024. Each investigator has a profile showing what they cite most.
When was Taenaka Kogyo Co., Ltd. 452 Oshiba inspected by FDA?
The inspection ran Apr 8 – Apr 12, 2024, and the Form 483 is dated April 12, 2024.
How do I get the full Form 483 for Taenaka Kogyo Co., Ltd. 452 Oshiba?
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.