Fukuzyu Pharmaceutical Co., Ltd.
Form 483 issued January 19, 2024 · Toyama, Japan
- Inspection
- Jan 15 – Jan 19, 2024
- Investigator
- Nicholas L. Hunt
- Observations
- 4
- Pages
- 4
- FEI number
- 3002807025
In short: On January 19, 2024, FDA issued a Form 483 with 4 observations to Fukuzyu Pharmaceutical Co., Ltd. in Toyama, Toyama Prefecture (FEI 3002807025) after an inspection that ran Jan 15 – Jan 19, 2024. The investigator was Nicholas L. Hunt. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality unit does not always conduct thorough investigations for out-of-specification…
- 02
Shared production equipment is not always cleaned and maintained in a manner suitable to prevent cross…
- 03
Validation of analytical methods…
- 04
Appropriate procedures are not established and followed for control of computerized systems and electronic records…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmFukuzyu Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fukuzyu Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Fukuzyu Pharmaceutical Co., Ltd.?
Nicholas L. Hunt is named on this Form 483, for the inspection of Jan 15 – Jan 19, 2024. Each investigator has a profile showing what they cite most.
When was Fukuzyu Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 15 – Jan 19, 2024, and the Form 483 is dated January 19, 2024.
How do I get the full Form 483 for Fukuzyu Pharmaceutical 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.