Daito Pharmaceutical Co., Ltd.
Form 483 issued September 16, 2022 · Toyama-City, Japan
- Inspection
- Sep 12 – Sep 16, 2022
- Investigator
- Santiago Gallardo Johnson
- Observations
- 2
- Pages
- 2
- FEI number
- 3002806779
In short: On September 16, 2022, FDA issued a Form 483 with 2 observations to Daito Pharmaceutical Co., Ltd. in Toyama-City, Toyama (FEI 3002806779) after an inspection that ran Sep 12 – Sep 16, 2022. The investigator was Santiago Gallardo Johnson. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) 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 211.192
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Daito Pharmaceutical Co., Ltd.?
Santiago Gallardo Johnson is named on this Form 483, for the inspection of Sep 12 – Sep 16, 2022. Each investigator has a profile showing what they cite most.
When was Daito Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Sep 12 – Sep 16, 2022, and the Form 483 is dated September 16, 2022.
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.