Kyowa Hakko Bio Co., Ltd.
Form 483 issued November 8, 2019 · Hofu, Japan
- Inspection
- Oct 28 – Nov 8, 2019
- Observations
- 1
- Pages
- 1
- FEI number
- 3002807424
In short: On November 8, 2019, FDA issued a Form 483 with 1 observation to Kyowa Hakko Bio Co., Ltd. in Hofu, Yamaguchi (FEI 3002807424) after an inspection that ran Oct 28 – Nov 8, 2019. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
This inspection in context
Questions about this 483
What did FDA find at Kyowa Hakko Bio Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Kyowa Hakko Bio Co., Ltd. inspected by FDA?
The inspection ran Oct 28 – Nov 8, 2019, and the Form 483 is dated November 8, 2019.
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.