Fuji Yakuhin Co., Ltd.
Form 483 issued November 25, 2022 · Toyama-Shi, Japan
- Inspection
- Nov 17 – Nov 25, 2022
- Investigator
- Robert J. Martin
- Observations
- 3
- Pages
- 4
- FEI number
- 3008538640
In short: On November 25, 2022, FDA issued a Form 483 with 3 observations to Fuji Yakuhin Co., Ltd. in Toyama-Shi, Toyama (FEI 3008538640) after an inspection that ran Nov 17 – Nov 25, 2022. The investigator was Robert J. Martin. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program…
- 03
A sample which is representative of each lot in each shipment of each active…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmFuji Yakuhin Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fuji Yakuhin Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Fuji Yakuhin Co., Ltd.?
Robert J. Martin is named on this Form 483, for the inspection of Nov 17 – Nov 25, 2022. Each investigator has a profile showing what they cite most.
When was Fuji Yakuhin Co., Ltd. inspected by FDA?
The inspection ran Nov 17 – Nov 25, 2022, and the Form 483 is dated November 25, 2022.
How do I get the full Form 483 for Fuji Yakuhin 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.