Toyobo CO., Ltd.
Form 483 issued February 25, 2023 · Otsu, Japan
- Inspection
- Feb 15 – Feb 25, 2023
- Investigators
- Michael E. Maselli· Michele Perry Williams
- Observations
- 5
- Pages
- 4
- FEI number
- 1000251214
In short: On February 25, 2023, FDA issued a Form 483 with 5 observations to Toyobo CO., Ltd. in Otsu, Shiga (FEI 1000251214) after an inspection that ran Feb 15 – Feb 25, 2023. The investigators were Michael E. Maselli and Michele Perry Williams. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
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 did not include…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Michael E. Maselli
6 documents · 2015–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Colorado.
The firmToyobo CO., Ltd. history
All 5 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 Toyobo CO., Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls 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 Toyobo CO., Ltd.?
Michael E. Maselli and Michele Perry Williams are named on this Form 483, for the inspection of Feb 15 – Feb 25, 2023. Each investigator has a profile showing what they cite most.
When was Toyobo CO., Ltd. inspected by FDA?
The inspection ran Feb 15 – Feb 25, 2023, and the Form 483 is dated February 25, 2023.
How do I get the full Form 483 for Toyobo 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.