Amsino Healthcare (USA) Inc.
Form 483 issued November 13, 2023 · Vernon Hills, Illinois
- Inspection
- Nov 9 – Nov 13, 2023
- Observations
- 4
- Pages
- 5
- FEI number
- 1417519
In short: On November 13, 2023, FDA issued a Form 483 with 4 observations to Amsino Healthcare (USA) Inc. in Vernon Hills, Illinois (FEI 1417519) after an inspection that ran Nov 9 – Nov 13, 2023. Most observations concern quality system and cAPA.
At a glance
Quality system and capa account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not fully followed. mple collected…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Questions about this 483
What did FDA find at Amsino Healthcare (USA) Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system and cAPA. The opening words of each observation are shown on this page.
When was Amsino Healthcare (USA) Inc. inspected by FDA?
The inspection ran Nov 9 – Nov 13, 2023, and the Form 483 is dated November 13, 2023.
How do I get the full Form 483 for Amsino Healthcare (USA) 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.