Miyoshi America, Inc.
Form 483 issued May 25, 2021 · Dayville, Connecticut
- Inspection
- May 5, 2020 – May 25, 2021
- Investigators
- Jonah S. Ufferfilge· Samir C. Gala
- Observations
- 6
- Pages
- 8
- FEI number
- 3009481791
In short: On May 25, 2021, FDA issued a Form 483 with 6 observations to Miyoshi America, Inc. in Dayville, Connecticut (FEI 3009481791) after an inspection that ran May 5, 2020 – May 25, 2021. The investigators were Jonah S. Ufferfilge and Samir C. Gala. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to extend investigations to other lots that may have been associated…
- 02
The firm failed to establish corrective actions in a…
- 03
Your firm failed to have proper cleaning procedures to avoid any cross contamination or mix up…
- 04
Your firm’s Preventative Maintenance…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmMiyoshi America, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Miyoshi America, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Miyoshi America, Inc.?
Jonah S. Ufferfilge and Samir C. Gala are named on this Form 483, for the inspection of May 5, 2020 – May 25, 2021. Each investigator has a profile showing what they cite most.
When was Miyoshi America, Inc. inspected by FDA?
The inspection ran May 5, 2020 – May 25, 2021, and the Form 483 is dated May 25, 2021.
How do I get the full Form 483 for Miyoshi America, Inc.?
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.