Amsino Healthcare (USA) Inc.
Form 483 issued September 20, 2021 · Vernon Hills, Illinois
- Inspection
- Sep 7 – Sep 20, 2021
- Investigator
- Michele L. Glendenning
- Observations
- 10
- Pages
- 13
- FEI number
- 1417519
In short: On September 20, 2021, FDA issued a Form 483 with 10 observations to Amsino Healthcare (USA) Inc. in Vernon Hills, Illinois (FEI 1417519) after an inspection that ran Sep 7 – Sep 20, 2021. The investigator was Michele L. Glendenning. Most observations concern facilities & equipment and cAPA; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for corrective and preventive action have…
- 03
Corrective and preventive action activities and/or results have not…
- 04
No management representative had been appointed to ensure that quality system requirements are met, and to…
This inspection in context
Michele L. Glendenning
18 documents · 2018–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
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 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amsino Healthcare (USA) Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, cAPA and quality system. 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 Amsino Healthcare (USA) Inc.?
Michele L. Glendenning is named on this Form 483, for the inspection of Sep 7 – Sep 20, 2021. Each investigator has a profile showing what they cite most.
When was Amsino Healthcare (USA) Inc. inspected by FDA?
The inspection ran Sep 7 – Sep 20, 2021, and the Form 483 is dated September 20, 2021.
How do I get the full Form 483 for Amsino Healthcare (USA) Inc.?
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