Toyobo CO., Ltd.
Form 483 issued January 23, 2018 · Otsu, Japan
- Inspection
- Jan 15 – Jan 23, 2018
- Investigators
- Marion Michaelis· Steven Fong
- Observations
- 5
- Pages
- 3
- FEI number
- 1000251214
In short: On January 23, 2018, FDA issued a Form 483 with 5 observations to Toyobo CO., Ltd. in Otsu, Shiga -R (FEI 1000251214) after an inspection that ran Jan 15 – Jan 23, 2018. The investigators were Marion Michaelis and Steven Fong. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
Most cited: 21 CFR 211.68 (2×) · 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
Your firm failed to ensure that laboratory records used to support? manufacturing included accurate data derived…
- 02
There are no procedures for adequately verifying changes or modifications…
- 03
Aseptic processing areas are deficient regarding the system for disinfecting the room and equipment…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Marion Michaelis
5 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Japan.
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 211.68
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 facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Toyobo CO., Ltd.?
Marion Michaelis and Steven Fong are named on this Form 483, for the inspection of Jan 15 – Jan 23, 2018. Each investigator has a profile showing what they cite most.
When was Toyobo CO., Ltd. inspected by FDA?
The inspection ran Jan 15 – Jan 23, 2018, and the Form 483 is dated January 23, 2018.
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.