Kyowa Pharma Chemical Co., Ltd.
Form 483 issued December 9, 2022 · Takaoka, Japan
- Inspection
- Dec 5 – Dec 9, 2022
- Investigator
- Noreen Muniz
- Observations
- 8
- Pages
- 5
- FEI number
- 3003128853
In short: On December 9, 2022, FDA issued a Form 483 with 8 observations to Kyowa Pharma Chemical Co., Ltd. in Takaoka, Toyama (FEI 3003128853) after an inspection that ran Dec 5 – Dec 9, 2022. The investigator was Noreen Muniz. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Responsibilities of the Quality Unit…
- 02
Cleaning validation studies conducted for shared and non-shared equipment in use at Manufacturing Building (OY) for…
- 03
Cleaning activities performed as part of changes between different products (change over) included with Cleaning Operation…
- 04
Forms used to record equipment use and cleaning (Form M-MU-0114-03-1) at Building @))ido not include specific…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmKyowa Pharma Chemical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kyowa Pharma Chemical Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Kyowa Pharma Chemical Co., Ltd.?
Noreen Muniz is named on this Form 483, for the inspection of Dec 5 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was Kyowa Pharma Chemical Co., Ltd. inspected by FDA?
The inspection ran Dec 5 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
How do I get the full Form 483 for Kyowa Pharma Chemical 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.