Nippon Protein
Form 483 issued June 27, 2025 · Ashikaga, Japan
- Observations
- 3
- Pages
- 2
- FEI number
- 3004310658
In short: On June 27, 2025, FDA issued a Form 483 with 3 observations to Nippon Protein in Ashikaga, Tochigi (FEI 3004310658). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 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
Failure to perform a thorough…
- 02
Failure to validate cleaning…
- 03
Failure to perform routine…
This inspection in context
Questions about this 483
What did FDA find at Nippon Protein?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Nippon Protein inspected by FDA?
This Form 483 is dated June 27, 2025.
How do I get the full Form 483 for Nippon Protein?
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.