Kinkando CO., Ltd.
Form 483 issued May 9, 2025 · HONJO-SHI, Japan
- Inspection
- May 6 – May 9, 2025
- Investigator
- Monica E. Murie
- Observations
- 5
- Pages
- 5
- FEI number
- 3004016987
In short: On May 9, 2025, FDA issued a Form 483 with 5 observations to Kinkando CO., Ltd. in HONJO-SHI, SAITAMA (FEI 3004016987) after an inspection that ran May 6 – May 9, 2025. The investigator was Monica E. Murie. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Production and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards, sampling plans, and…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmKinkando CO., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kinkando CO., Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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.
Who inspected Kinkando CO., Ltd.?
Monica E. Murie is named on this Form 483, for the inspection of May 6 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was Kinkando CO., Ltd. inspected by FDA?
The inspection ran May 6 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for Kinkando 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.