Miyoshi America, Inc.
Form 483 issued January 13, 2023 · Dayville, Connecticut
- Inspection
- Jan 4 – Jan 13, 2023
- Observations
- 3
- Pages
- 3
- FEI number
- 3009481791
In short: On January 13, 2023, FDA issued a Form 483 with 3 observations to Miyoshi America, Inc. in Dayville, Connecticut (FEI 3009481791) after an inspection that ran Jan 4 – Jan 13, 2023. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
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 establish and conduct adequate cleaning procedures to prevent potential cross contamination of…
- 02
You firm failed to exercise sufficient control over computerized laboratory systems to prevent unauthorized deletion of…
- 03
Your firm failed to establish laboratory control records that include complete data derived from all laboratory…
This inspection in context
Questions about this 483
What did FDA find at Miyoshi America, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
When was Miyoshi America, Inc. inspected by FDA?
The inspection ran Jan 4 – Jan 13, 2023, and the Form 483 is dated January 13, 2023.
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.