Kyowa Hakko Bio Co., Ltd.
Form 483 issued April 15, 2022 · Hofu-city, Japan
- Inspection
- Apr 11 – Apr 15, 2022
- Investigator
- Teresa I. Navas
- Observations
- 5
- Pages
- 4
- FEI number
- 3002807
In short: On April 15, 2022, FDA issued a Form 483 with 5 observations to Kyowa Hakko Bio Co., Ltd. in Hofu-city, Japan (FEI 3002807) after an inspection that ran Apr 11 – Apr 15, 2022. The investigator was Teresa I. Navas. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
a)The potential impact of the proposed change on the quality of the intermediate or…
- 03
Materials System Your firm does not have evidence to demonstrate that the current monitoring frequency and…
- 04
Your finn laboratory controls…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmKyowa Hakko Bio Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kyowa Hakko Bio Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Kyowa Hakko Bio Co., Ltd.?
Teresa I. Navas is named on this Form 483, for the inspection of Apr 11 – Apr 15, 2022. Each investigator has a profile showing what they cite most.
When was Kyowa Hakko Bio Co., Ltd. inspected by FDA?
The inspection ran Apr 11 – Apr 15, 2022, and the Form 483 is dated April 15, 2022.
How do I get the full Form 483 for Kyowa Hakko Bio 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.