Otsuka Pharmaceutical Co., Ltd.
Form 483 issued February 1, 2019 · OMAGARI, Japan
- Inspection
- Jan 28 – Feb 1, 2019
- Investigator
- Zachary L. Stamm
- Observations
- 2
- Pages
- 2
- FEI number
- 3003808559
In short: On February 1, 2019, FDA issued a Form 483 with 2 observations to Otsuka Pharmaceutical Co., Ltd. in OMAGARI, Saga (FEI 3003808559) after an inspection that ran Jan 28 – Feb 1, 2019. The investigator was Zachary L. Stamm. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.142 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into unexpected discrepancies are not…
- 02
There is not adequate control to ensure the temperature of the warehouse used to store raw…
This inspection in context
Zachary L. Stamm
13 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmOtsuka Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
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 2 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Otsuka Pharmaceutical Co., Ltd.?
Zachary L. Stamm is named on this Form 483, for the inspection of Jan 28 – Feb 1, 2019. Each investigator has a profile showing what they cite most.
When was Otsuka Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 28 – Feb 1, 2019, and the Form 483 is dated February 1, 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.