Nissui Corporation
Form 483 issued December 15, 2023 · TSUKUBA, Japan
- Inspection
- Dec 11 – Dec 15, 2023
- Investigator
- Jolanna A. Norton
- Observations
- 2
- Pages
- 2
- FEI number
- 3004317885
In short: On December 15, 2023, FDA issued a Form 483 with 2 observations to Nissui Corporation in TSUKUBA, IBARAKI (FEI 3004317885) after an inspection that ran Dec 11 – Dec 15, 2023. The investigator was Jolanna A. Norton. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.166(a) (1×) · 211.67(b)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmNissui Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nissui Corporation?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Nissui Corporation?
Jolanna A. Norton is named on this Form 483, for the inspection of Dec 11 – Dec 15, 2023. Each investigator has a profile showing what they cite most.
When was Nissui Corporation inspected by FDA?
The inspection ran Dec 11 – Dec 15, 2023, and the Form 483 is dated December 15, 2023.
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.