Tokyo Chemical Industry Co., Ltd.
Form 483 issued October 19, 2018 · Fukaya, Japan
- Inspection
- Oct 15 – Oct 19, 2018
- Investigator
- Niketa Patel
- Observations
- 3
- Pages
- 2
- FEI number
- 3002808353
In short: On October 19, 2018, FDA issued a Form 483 with 3 observations to Tokyo Chemical Industry Co., Ltd. in Fukaya, Saitama (FEI 3002808353) after an inspection that ran Oct 15 – Oct 19, 2018. The investigator was Niketa Patel. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your…
- 02
The firm failed to exercise appropriate controls over computers or related systems to prevent deletion of…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmTokyo Chemical Industry Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Tokyo Chemical Industry Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Tokyo Chemical Industry Co., Ltd.?
Niketa Patel is named on this Form 483, for the inspection of Oct 15 – Oct 19, 2018. Each investigator has a profile showing what they cite most.
When was Tokyo Chemical Industry Co., Ltd. inspected by FDA?
The inspection ran Oct 15 – Oct 19, 2018, and the Form 483 is dated October 19, 2018.
How do I get the full Form 483 for Tokyo 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.