Sumitomo Pharma Co., Ltd.
Form 483 issued April 16, 2019 · Oita, Japan
- Inspection
- Apr 8 – Apr 16, 2019
- Investigators
- Linda F. Murphy· Zhongren Wu
- Observations
- 3
- Pages
- 3
- FEI number
- 3005619533
In short: On April 16, 2019, FDA issued a Form 483 with 3 observations to Sumitomo Pharma Co., Ltd. in Oita, Oita (FEI 3005619533) after an inspection that ran Apr 8 – Apr 16, 2019. The investigators were Linda F. Murphy and Zhongren Wu. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Media used during routine environmental monitoring has not been demonstrated to promote growth of gram-positive and…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmSumitomo Pharma Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sumitomo Pharma Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Sumitomo Pharma Co., Ltd.?
Linda F. Murphy and Zhongren Wu are named on this Form 483, for the inspection of Apr 8 – Apr 16, 2019. Each investigator has a profile showing what they cite most.
When was Sumitomo Pharma Co., Ltd. inspected by FDA?
The inspection ran Apr 8 – Apr 16, 2019, and the Form 483 is dated April 16, 2019.
How do I get the full Form 483 for Sumitomo Pharma 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.