Sumitomo Pharma Co., Ltd.
Amended 483 issued July 11, 2025 · Oita, Japan
- Inspection
- Jul 3 – Jul 11, 2025
- Investigators
- Anastasia M. Shields· Jessica S. Estriplet
- Observations
- 4
- Pages
- 5
- FEI number
- 3005619533
In short: On July 11, 2025, FDA issued a Amended 483 with 4 observations to Sumitomo Pharma Co., Ltd. in Oita, Oita (FEI 3005619533) after an inspection that ran Jul 3 – Jul 11, 2025. The investigators were Anastasia M. Shields and Jessica S. Estriplet. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) 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 documentsOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Sumitomo Pharma Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sumitomo Pharma Co., Ltd.?
Anastasia M. Shields and Jessica S. Estriplet are named on this Amended 483, for the inspection of Jul 3 – Jul 11, 2025. Each investigator has a profile showing what they cite most.
When was Sumitomo Pharma Co., Ltd. inspected by FDA?
The inspection ran Jul 3 – Jul 11, 2025, and the Amended 483 is dated July 11, 2025.
How do I get the full Amended 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.