International Chemical Entity Japan Co., Ltd.
Form 483 issued March 22, 2019 · Iwaki, Japan
- Inspection
- Mar 18 – Mar 22, 2019
- Investigator
- Rumany C. Penn
- Observations
- 2
- Pages
- 2
- FEI number
- 3004546088
In short: On March 22, 2019, FDA issued a Form 483 with 2 observations to International Chemical Entity Japan Co., Ltd. in Iwaki, Fukushima (FEI 3004546088) after an inspection that ran Mar 18 – Mar 22, 2019. The investigator was Rumany C. Penn. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmInternational Chemical Entity Japan Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Chemical Entity Japan Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected International Chemical Entity Japan Co., Ltd.?
Rumany C. Penn is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2019. Each investigator has a profile showing what they cite most.
When was International Chemical Entity Japan Co., Ltd. inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2019, and the Form 483 is dated March 22, 2019.
How do I get the full Form 483 for International Chemical Entity Japan 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.