Sumitomo Chemical Company, Limited
Form 483 issued September 23, 2016 · Ampachicho, Japan
- Inspection
- Sep 20, 2014 – Sep 23, 2016
- Investigators
- Lindsey M. Staley· Nona M. Shultis
- Observations
- 3
- Pages
- 3
- FEI number
- 3002808125
In short: On September 23, 2016, FDA issued a Form 483 with 3 observations to Sumitomo Chemical Company, Limited in Ampachicho, Gifu (FEI 3002808125) after an inspection that ran Sep 20, 2014 – Sep 23, 2016. The investigators were Lindsey M. Staley and Nona M. Shultis. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.160 (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 conduct laboratory investigations into unexplained discrepancies and…
- 02
Failure to follow the official procedures used to…
- 03
Document control of production batch records by the…
This inspection in context
Lindsey M. Staley
1 document · 2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Japan.
The firmSumitomo Chemical Company, Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Sumitomo Chemical Company, Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. 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 Sumitomo Chemical Company, Limited?
Lindsey M. Staley and Nona M. Shultis are named on this Form 483, for the inspection of Sep 20, 2014 – Sep 23, 2016. Each investigator has a profile showing what they cite most.
When was Sumitomo Chemical Company, Limited inspected by FDA?
The inspection ran Sep 20, 2014 – Sep 23, 2016, and the Form 483 is dated September 23, 2016.
How do I get the full Form 483 for Sumitomo Chemical Company, Limited?
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