Toyobo CO., Ltd.
Form 483 issued July 30, 2019 · Otsu, Japan
- Inspection
- Jul 30, 2019
- Investigators
- Sarah E. Rhoades· Steven E. Bowen
- Observations
- 3
- Pages
- 3
- FEI number
- 1000251214
In short: On July 30, 2019, FDA issued a Form 483 with 3 observations to Toyobo CO., Ltd. in Otsu, Japan (FEI 1000251214) after an inspection that ran Jul 30, 2019. The investigators were Sarah E. Rhoades and Steven E. Bowen. Most observations concern production and quality system.
At a glance
Production and quality system 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
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Sarah E. Rhoades
14 documents · 2017–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Toyobo CO., Ltd.?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Toyobo CO., Ltd.?
Sarah E. Rhoades and Steven E. Bowen are named on this Form 483, for the inspection of Jul 30, 2019. Each investigator has a profile showing what they cite most.
When was Toyobo CO., Ltd. inspected by FDA?
The inspection ran Jul 30, 2019, and the Form 483 is dated July 30, 2019.
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.