Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi
Form 483 issued November 17, 2017 · Iwaki-shi, Japan
- Inspection
- Nov 13 – Nov 17, 2017
- Investigator
- Arsen Karapetyan
- Observations
- 1
- Pages
- 8
- FEI number
- 3002808534
In short: On November 17, 2017, FDA issued a Form 483 with 1 observation to Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi in Iwaki-shi, Japan (FEI 3002808534) after an inspection that ran Nov 13 – Nov 17, 2017. The investigator was Arsen Karapetyan. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory control procedures are…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmYuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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 Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi?
Arsen Karapetyan is named on this Form 483, for the inspection of Nov 13 – Nov 17, 2017. Each investigator has a profile showing what they cite most.
When was Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi inspected by FDA?
The inspection ran Nov 13 – Nov 17, 2017, and the Form 483 is dated November 17, 2017.
How do I get the full Form 483 for Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi?
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