Shionogi Pharma Co., Ltd.
Form 483 issued July 1, 2025 · Kanegasaki, Japan
- Inspection
- Jun 23 – Jul 1, 2025
- Investigators
- Anastasia M. Shields· Jessica S. Estriplet
- Observations
- 4
- Pages
- 6
- FEI number
- 3002808135
In short: On July 1, 2025, FDA issued a Form 483 with 4 observations to Shionogi Pharma Co., Ltd. in Kanegasaki, Iwate (FEI 3002808135) after an inspection that ran Jun 23 – Jul 1, 2025. The investigators were Anastasia M. Shields and Jessica S. Estriplet. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 4 of 4 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shionogi Pharma Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Shionogi Pharma Co., Ltd.?
Anastasia M. Shields and Jessica S. Estriplet are named on this Form 483, for the inspection of Jun 23 – Jul 1, 2025. Each investigator has a profile showing what they cite most.
When was Shionogi Pharma Co., Ltd. inspected by FDA?
The inspection ran Jun 23 – Jul 1, 2025, and the Form 483 is dated July 1, 2025.
How do I get the full Form 483 for Shionogi Pharma Co., Ltd.?
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