Daito Pharmaceutical Co., Ltd.
Form 483 issued January 31, 2020 · Toyama-City, Japan
- Inspection
- Jan 27 – Jan 31, 2020
- Investigator
- Cheryl Clausen
- Observations
- 10
- Pages
- 3
- FEI number
- 3002806779
In short: On January 31, 2020, FDA issued a Form 483 with 10 observations to Daito Pharmaceutical Co., Ltd. in Toyama-City, Toyama (FEI 3002806779) after an inspection that ran Jan 27 – Jan 31, 2020. The investigator was Cheryl Clausen. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 3 systems, led by facilities & equipment.
Most cited: 21 CFR 211.68 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls are not always followed and documented at the time of performance to ensure all…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Computerized systems do not have adequate controls to prevent unauthorized access or changes to data in…
- 04
Validation of computerized systems did not include testing to demonstrate suitability for use such as: boundary…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Daito Pharmaceutical Co., Ltd.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Daito Pharmaceutical Co., Ltd.?
Cheryl Clausen is named on this Form 483, for the inspection of Jan 27 – Jan 31, 2020. Each investigator has a profile showing what they cite most.
When was Daito Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 27 – Jan 31, 2020, and the Form 483 is dated January 31, 2020.
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.