Daito Pharmaceutical Co., Ltd.
Form 483 issued November 10, 2017 · Toyama-City, Japan
- Inspection
- Nov 6 – Nov 10, 2017
- Investigator
- Arsen Karapetyan
- Observations
- 8
- Pages
- 8
- FEI number
- 3002806779
In short: On November 10, 2017, FDA issued a Form 483 with 8 observations to Daito Pharmaceutical Co., Ltd. in Toyama-City, Toyama (FEI 3002806779) after an inspection that ran Nov 6 – Nov 10, 2017. The investigator was Arsen Karapetyan. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
6 of 8 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (5×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory control procedures are…
- 02
Supervisory oversight over the laboratory electronic systems…
- 03
Laboratory records are not…
- 04
The Quality Unit lacks adequate…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Daito Pharmaceutical Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Daito Pharmaceutical Co., Ltd.?
Arsen Karapetyan is named on this Form 483, for the inspection of Nov 6 – Nov 10, 2017. Each investigator has a profile showing what they cite most.
When was Daito Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Nov 6 – Nov 10, 2017, and the Form 483 is dated November 10, 2017.
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.