Daito Pharmaceutical Co., Ltd.
Form 483 issued December 19, 2023 · Toyama-City, Japan
- Inspection
- Dec 11 – Dec 19, 2023
- Investigator
- Truong X. Nguyen
- Observations
- 2
- Pages
- 1
- FEI number
- 3002806779
In short: On December 19, 2023, FDA issued a Form 483 with 2 observations to Daito Pharmaceutical Co., Ltd. in Toyama-City, Toyama (FEI 3002806779) after an inspection that ran Dec 11 – Dec 19, 2023. The investigator was Truong X. Nguyen. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67(b) (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmDaito Pharmaceutical Co., Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Daito Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment 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 Daito Pharmaceutical Co., Ltd.?
Truong X. Nguyen is named on this Form 483, for the inspection of Dec 11 – Dec 19, 2023. Each investigator has a profile showing what they cite most.
When was Daito Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Dec 11 – Dec 19, 2023, and the Form 483 is dated December 19, 2023.
How do I get the full Form 483 for Daito 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.