Sumitomo Chemical Company, Limited
Form 483 issued September 6, 2019 · Ampachicho, Japan
- Inspection
- Sep 2 – Sep 6, 2019
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 2
- FEI number
- 3002808125
In short: On September 6, 2019, FDA issued a Form 483 with 3 observations to Sumitomo Chemical Company, Limited in Ampachicho, Gifu (FEI 3002808125) after an inspection that ran Sep 2 – Sep 6, 2019. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system 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
Your firm does not conduct meaningful review of audit trail for the HPLC instruments used to…
- 02
Your firm has elected to delegate the independent Quality Assurance (QA) duty and responsibility of approving…
- 03
Your firm’s ()@) Certificates of Analysis (COA) lack defined acceptance criteria and actual results for the…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.68
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 facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Sumitomo Chemical Company, Limited?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Sep 2 – Sep 6, 2019. Each investigator has a profile showing what they cite most.
When was Sumitomo Chemical Company, Limited inspected by FDA?
The inspection ran Sep 2 – Sep 6, 2019, and the Form 483 is dated September 6, 2019.
How do I get the full Form 483 for Sumitomo Chemical Company, Limited?
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.