Taiho Pharmaceutical Co., Ltd.
Form 483 issued January 26, 2024 · Takabo, Japan
- Inspection
- Jan 22 – Jan 26, 2024
- Observations
- 2
- Pages
- 2
- FEI number
- 3010872322
In short: On January 26, 2024, FDA issued a Form 483 with 2 observations to Taiho Pharmaceutical Co., Ltd. in Takabo, Tokushima (FEI 3010872322) after an inspection that ran Jan 22 – Jan 26, 2024. 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
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68(a) (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Routine inspection and checking of automatic and mechanical equipment is not performed according to a written…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
This inspection in context
Questions about this 483
What did FDA find at Taiho 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 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Taiho Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 22 – Jan 26, 2024, and the Form 483 is dated January 26, 2024.
How do I get the full Form 483 for Taiho 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.