# FDA 483 - ISOVAC Products, LLC - May 11, 2023

Source: https://www.keypedia.com/records/483/isovac-products-llc/08e71862-4c09-4487-ad1c-6cea124926d5

> FDA 483 for ISOVAC Products, LLC on May 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ISOVAC Products, LLC
- Inspection Date: 2023-05-11
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of ISOVAC Products, LLC in Romeoville, IL, a manufacturer of CAPSULS Patient Isolation Units, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures for accepting in-process products, specifically regarding alarm testing for blowers. Additionally, the inspection found a lack of established procedures for supplier evaluation and control, and a failure to adequately document corrective and preventive action effectiveness checks.

## Related Documents

- [483 - 2020-02-28](https://www.keypedia.com/records/483/isovac-products-llc/4f44f662-4b99-4f50-bc4b-2181d088d460)

## Related Officers

- [Brittani N. Franklin](https://www.keypedia.com/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

Company: https://www.keypedia.com/companies/isovac-products-llc/e76a5501-93ec-497f-8af4-92d23bb2e5f9

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