Otsuka Pharmaceutical Co Ltd.
Form 483 issued October 22, 2019 · KONIU, Japan
- Inspection
- Oct 15 – Oct 22, 2019
- Investigator
- Pratik S. Upadhyay
- Observations
- 7
- Pages
- 13
- FEI number
- 3004810250
In short: On October 22, 2019, FDA issued a Form 483 with 7 observations to Otsuka Pharmaceutical Co Ltd. in KONIU, Tokushima (FEI 3004810250) after an inspection that ran Oct 15 – Oct 22, 2019. The investigator was Pratik S. Upadhyay. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written records of investigation of a drug complaint do not include the findings of the…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Otsuka Pharmaceutical Co Ltd.?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Otsuka Pharmaceutical Co Ltd.?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Oct 15 – Oct 22, 2019. Each investigator has a profile showing what they cite most.
When was Otsuka Pharmaceutical Co Ltd. inspected by FDA?
The inspection ran Oct 15 – Oct 22, 2019, and the Form 483 is dated October 22, 2019.
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.