Shionogi Pharma Co., Ltd.
Form 483 issued August 5, 2016 · Tokushima, Japan
- Inspection
- Aug 1 – Aug 5, 2016
- Investigator
- Cheryl Clausen
- Observations
- 12
- Pages
- 7
- FEI number
- 3008353674
In short: On August 5, 2016, FDA issued a Form 483 with 12 observations to Shionogi Pharma Co., Ltd. in Tokushima, Tokushima (FEI 3008353674) after an inspection that ran Aug 1 – Aug 5, 2016. The investigator was Cheryl Clausen. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.68 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You can’t ensure your QC Laboratory records include complete and accurate data derived from all tests…
- 02
Computerized systems do not have sufficient control to prevent unauthorized access…
- 04
Your Quality Assurance unit has not established, documented, and implemented an effective system for…
- 05
Your Quality Assurance unit did not ensure you have stability data to monitor the stability characteristics…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shionogi Pharma Co., Ltd.?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Shionogi Pharma Co., Ltd.?
Cheryl Clausen is named on this Form 483, for the inspection of Aug 1 – Aug 5, 2016. Each investigator has a profile showing what they cite most.
When was Shionogi Pharma Co., Ltd. inspected by FDA?
The inspection ran Aug 1 – Aug 5, 2016, and the Form 483 is dated August 5, 2016.
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.