Stella Chemifa Corporation
Form 483 issued September 22, 2023 · IZUMIOOTSU, Japan
- Inspection
- Sep 19 – Sep 22, 2023
- Investigators
- Lisa R. Hilliard· Wen Ning Chan
- Observations
- 2
- Pages
- 2
- FEI number
- 3003845224
In short: On September 22, 2023, FDA issued a Form 483 with 2 observations to Stella Chemifa Corporation in IZUMIOOTSU, OSAKA (FEI 3003845224) after an inspection that ran Sep 19 – Sep 22, 2023. The investigators were Lisa R. Hilliard and Wen Ning Chan. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×) · 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
Deficiencies were observed with your accelerated stability program for…
- 02
Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmStella Chemifa Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stella Chemifa Corporation?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Stella Chemifa Corporation?
Lisa R. Hilliard and Wen Ning Chan are named on this Form 483, for the inspection of Sep 19 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Stella Chemifa Corporation inspected by FDA?
The inspection ran Sep 19 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
How do I get the full Form 483 for Stella Chemifa Corporation?
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.