Shionogi Pharma Co., Ltd.
Form 483 issued March 15, 2019 · Kanegasaki, Japan
- Inspection
- Mar 4 – Mar 15, 2019
- Investigator
- Jiao Yang
- Observations
- 2
- Pages
- 2
- FEI number
- 3002808135
In short: On March 15, 2019, FDA issued a Form 483 with 2 observations to Shionogi Pharma Co., Ltd. in Kanegasaki, Iwate (FEI 3002808135) after an inspection that ran Mar 4 – Mar 15, 2019. The investigator was Jiao Yang. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.56 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your facility cleaning procedures in Building} Jare deficient, in that they do not include full details…
- 02
Your production batch records do not always identify all facility building location and room numbers; and/or…
This inspection in context
Jiao Yang
1 document · 2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Japan.
The firmShionogi Pharma 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 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shionogi Pharma Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Shionogi Pharma Co., Ltd.?
Jiao Yang is named on this Form 483, for the inspection of Mar 4 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Shionogi Pharma Co., Ltd. inspected by FDA?
The inspection ran Mar 4 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Shionogi Pharma 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.