Miyoshi America, Inc.
FDA inspection history in Dayville, Connecticut, 2021 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s, at Dayville, Connecticut.
- 2021The longest 483 on file: 6 observations over 8 pages at Dayville, Connecticut.
Cited most
Across all Miyoshi America observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.115Reprocessing1
- 21 CFR 211.192Production record review1
The complete Miyoshi America file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Dayville, Connecticut
Two Form 483s · 2021 to 2023 · 9 observations
Latest: Form 483, Jan 13, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-13 | 483 Form 483 | Dayville, Connecticut | 3 | $99 |
| 2021-05-25 | 483 Form 483 | Dayville, Connecticut | 6 | $99 |
Investigators on these documents
FEI number 3009481791 · most recent document Jan 13, 2023
About Miyoshi America, Inc.
How many FDA Form 483s has Miyoshi America, Inc. received?
FDA Intel has 2 Form 483s on file for Miyoshi America, Inc.; the most recent is dated Jan 13, 2023.
When was Miyoshi America, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Miyoshi America, Inc. is a Form 483 dated Jan 13, 2023, for the site in Dayville, Connecticut.
What did FDA cite at Miyoshi America, Inc.?
The regulations cited most in the observations on file for Miyoshi America, Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.194 (Laboratory records), 2 times.