Shionogi Pharma Co., Ltd.
Form 483 issued October 20, 2023 · Tokushima, Japan
- Observations
- 4
- Pages
- 6
- FEI number
- 3008353674
In short: On October 20, 2023, FDA issued a Form 483 with 4 observations to Shionogi Pharma Co., Ltd. in Tokushima, Tokushima (FEI 3008353674). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Out of Specification investigation is not thorough and appropriate preventive action is…
- 02
Analytical Methods are not appropriately…
- 03
Appropriate laboratory controls are…
- 04
Representative samples are not taken…
This inspection in context
Questions about this 483
What did FDA find at Shionogi Pharma Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Shionogi Pharma Co., Ltd. inspected by FDA?
This Form 483 is dated October 20, 2023.
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.