Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho
Form 483 issued November 22, 2019 · Suzuka, Japan
- Observations
- 1
- Pages
- 1
- FEI number
- 3003028650
In short: On November 22, 2019, FDA issued a Form 483 with 1 observation to Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho in Suzuka, Mie (FEI 3003028650). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho inspected by FDA?
This Form 483 is dated November 22, 2019.
How do I get the full Form 483 for Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho?
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.