# FDA 483 - Amsino Healthcare (USA) Inc - September 20, 2021

Source: https://www.globalkeysolutions.net/records/483/amsino-healthcare-usa-inc/80190cec-aa05-4bcc-9a5e-ccef817381aa

> FDA 483 for Amsino Healthcare (USA) Inc on September 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amsino Healthcare (USA) Inc
- Inspection Date: 2021-09-20
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Amsino Healthcare (USA) Inc. in Vernon Hills, IL, was cited for multiple deficiencies during an FDA inspection from September 7-20, 2021. Key issues include inadequate process validation for smoke studies, poorly established and documented corrective and preventive actions, and a failure to appoint a permanent Quality Director. The firm also had issues with equipment cleaning, thoroughness of investigations into discrepancies and batch failures, and procedures for preventing microbiological contamination of sterile drug products.

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## Related Officers

- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/amsino-healthcare-usa-inc/27a69edc-8786-4674-a706-95daf6714a37

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669