Shiono Finesse, Ltd.
Form 483 issued June 8, 2018 · SAKAI, Japan
- Inspection
- Jun 6 – Jun 8, 2018
- Investigator
- Yasmin Ameri
- Observations
- 8
- Pages
- 3
- FEI number
- 3005940219
In short: On June 8, 2018, FDA issued a Form 483 with 8 observations to Shiono Finesse, Ltd. in SAKAI, FUKUI (FEI 3005940219) after an inspection that ran Jun 6 – Jun 8, 2018. The investigator was Yasmin Ameri. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and materials account for 5 of 8 observations.
Most cited: 21 CFR 211.67 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computer generated data should be reviewed electronically to ensure accuracy and integrity of the data entered…
- 02
Equipment used for production and processing of API and intermediates should be cleaned at appropriate intervals…
- 03
There should be a maintenance procedure and program in-place to define the maintenance requirement, schedule, and…
- 04
Process validation should be conducted under actual condition to ensure performance of manufacturing processes that may…
This inspection in context
Yasmin Ameri
1 document · 2018
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Japan.
The firmShiono Finesse, Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shiono Finesse, Ltd.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Shiono Finesse, Ltd.?
Yasmin Ameri is named on this Form 483, for the inspection of Jun 6 – Jun 8, 2018. Each investigator has a profile showing what they cite most.
When was Shiono Finesse, Ltd. inspected by FDA?
The inspection ran Jun 6 – Jun 8, 2018, and the Form 483 is dated June 8, 2018.
How do I get the full Form 483 for Shiono Finesse, 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.