Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Form 483 issued March 22, 2024 · Tokushima, Japan
- Inspection
- Mar 13 – Mar 22, 2024
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 5
- Pages
- 4
- FEI number
- 3002807834
In short: On March 22, 2024, FDA issued a Form 483 with 5 observations to Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. in Tokushima, Japan (FEI 3002807834) after an inspection that ran Mar 13 – Mar 22, 2024. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Deviations from written sampling…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmSecond Tokushima Factory, Otsuka 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 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Mar 13 – Mar 22, 2024. Each investigator has a profile showing what they cite most.
When was Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Mar 13 – Mar 22, 2024, and the Form 483 is dated March 22, 2024.
How do I get the full Form 483 for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.?
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