Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi
Form 483 issued July 28, 2021 · JOBANNISHIGOMACHI, Japan
- Observations
- 4
- Pages
- 3
- FEI number
- 3002808534
In short: On July 28, 2021, FDA issued a Form 483 with 4 observations to Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi in JOBANNISHIGOMACHI, FUKUSHIMA (FEI 3002808534). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×) · 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
Your Quality Unit failed to implement appropriate corrective and preventive actions (CAPA) in a timely manner…
- 02
istri S) is system that is used to monitor the in-process parameters (e.g., f the manufacturing…
- 03
There is a failure to conduct a comprehensive evaluation and implement appropriate and effective corrective and…
- 04
There is a failure to perform the working sample stability study as part of the…
This inspection in context
Questions about this 483
What did FDA find at Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi inspected by FDA?
This Form 483 is dated July 28, 2021.
How do I get the full Form 483 for Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi?
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.