Otsuka Pharmaceutical Co Ltd.
Form 483 issued June 17, 2025 · KONIU, Japan
- Inspection
- Jun 9 – Jun 17, 2025
- Investigator
- Bijoy Panicker
- Observations
- 4
- Pages
- 5
- FEI number
- 3004810250
In short: On June 17, 2025, FDA issued a Form 483 with 4 observations to Otsuka Pharmaceutical Co Ltd. in KONIU, Tokushima (FEI 3004810250) after an inspection that ran Jun 9 – Jun 17, 2025. The investigator was Bijoy Panicker. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmOtsuka Pharmaceutical 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Otsuka Pharmaceutical Co Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Otsuka Pharmaceutical Co Ltd.?
Bijoy Panicker is named on this Form 483, for the inspection of Jun 9 – Jun 17, 2025. Each investigator has a profile showing what they cite most.
When was Otsuka Pharmaceutical Co Ltd. inspected by FDA?
The inspection ran Jun 9 – Jun 17, 2025, and the Form 483 is dated June 17, 2025.
How do I get the full Form 483 for Otsuka Pharmaceutical 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.