Nissui Corporation
Form 483 issued November 11, 2022 · KAMISU, Japan
- Observations
- 3
- Pages
- 2
- FEI number
- 3009589537
In short: On November 11, 2022, FDA issued a Form 483 with 3 observations to Nissui Corporation in KAMISU, IBARAKI (FEI 3009589537). Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications…
- 02
Procedures for the cleaning of equipment are deficient regarding sufficient detail of the methods, equipment, and…
- 03
The master production and control records (MPR) are deficient in that they do not include complete…
This inspection in context
Questions about this 483
What did FDA find at Nissui Corporation?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Nissui Corporation inspected by FDA?
This Form 483 is dated November 11, 2022.
How do I get the full Form 483 for Nissui Corporation?
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.