Nippon Rika CO., Ltd.
Form 483 issued July 4, 2025 · ASHIKAGA, Japan
- Inspection
- Jun 30 – Jul 4, 2025
- Investigator
- Crystal Monroy
- Observations
- 7
- Pages
- 3
- FEI number
- 3002807731
In short: On July 4, 2025, FDA issued a Form 483 with 7 observations to Nippon Rika CO., Ltd. in ASHIKAGA, TOCHIGI (FEI 3002807731) after an inspection that ran Jun 30 – Jul 4, 2025. The investigator was Crystal Monroy. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The test procedures used in stability testing are not verified…
- 02
Control of quality control samples of raw materials, intermediates, and APIs are inadequate. Specially, (A) Your…
- 03
Laboratory control records are…
- 04
Appropriate controls are not exercised over…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmNippon Rika CO., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nippon Rika CO., Ltd.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Nippon Rika CO., Ltd.?
Crystal Monroy is named on this Form 483, for the inspection of Jun 30 – Jul 4, 2025. Each investigator has a profile showing what they cite most.
When was Nippon Rika CO., Ltd. inspected by FDA?
The inspection ran Jun 30 – Jul 4, 2025, and the Form 483 is dated July 4, 2025.
How do I get the full Form 483 for Nippon Rika CO., Ltd.?
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.