Amsino Healthcare (USA) Inc.
Form 483 issued December 19, 2022 · Vernon Hills, Illinois
- Inspection
- Dec 5 – Dec 19, 2022
- Investigators
- Joseph A. Piechocki· Shafig Ahadi· Shafiq S. Ahadi
- Observations
- 16
- Pages
- 21
- FEI number
- 1417519
In short: On December 19, 2022, FDA issued a Form 483 with 16 observations to Amsino Healthcare (USA) Inc. in Vernon Hills, Illinois (FEI 1417519) after an inspection that ran Dec 5 – Dec 19, 2022. The investigators were Joseph A. Piechocki, Shafig Ahadi, Shafiq S. Ahadi and Simone E. Pitts. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by design controls.
What FDA observed
Preview: the opening words of each observation- 01
A device master record…
- 02
Written MDR procedures have…
- 03
Procedures for design change…
- 04
The design history file…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAmsino Healthcare (USA) Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amsino Healthcare (USA) Inc.?
FDA listed 16 observations on this Form 483, mostly about design controls, cAPA and quality system. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Amsino Healthcare (USA) Inc.?
Joseph A. Piechocki, Shafig Ahadi, Shafiq S. Ahadi and Simone E. Pitts are named on this Form 483, for the inspection of Dec 5 – Dec 19, 2022. Each investigator has a profile showing what they cite most.
When was Amsino Healthcare (USA) Inc. inspected by FDA?
The inspection ran Dec 5 – Dec 19, 2022, and the Form 483 is dated December 19, 2022.
How do I get the full Form 483 for Amsino Healthcare (USA) Inc.?
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