Toyobo CO., Ltd.
Form 483 issued February 25, 2021 · Otsu, Japan
- Inspection
- Feb 15 – Feb 25, 2021
- Investigators
- Arsen Karapetyan· Roger F. Zabinski
- Observations
- 11
- Pages
- 14
- FEI number
- 1000251214
In short: On February 25, 2021, FDA issued a Form 483 with 11 observations to Toyobo CO., Ltd. in Otsu, Shiga (FEI 1000251214) after an inspection that ran Feb 15 – Feb 25, 2021. The investigators were Arsen Karapetyan and Roger F. Zabinski. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Production personnel were not practicing good…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Toyobo CO., Ltd.?
FDA listed 11 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Toyobo CO., Ltd.?
Arsen Karapetyan and Roger F. Zabinski are named on this Form 483, for the inspection of Feb 15 – Feb 25, 2021. 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, 2021, and the Form 483 is dated February 25, 2021.
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.