# FDA 483 - ISOVAC Products, LLC - February 28, 2020

Source: https://www.keypedia.com/records/483/isovac-products-llc/4f44f662-4b99-4f50-bc4b-2181d088d460

> FDA 483 for ISOVAC Products, LLC on February 28, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ISOVAC Products, LLC
- Inspection Date: 2020-02-28
- Product Type: device
- Office Name: Chicago District Office
- Summary: ISOVAC Products, LLC, a manufacturer of Class II Patient Isolation Units in Romeoville, IL, was inspected by the FDA. The inspection revealed significant deficiencies in process validation, design validation, medical device reporting procedures, and document control. These issues indicate a lack of adequate quality system controls for their medical devices.

## Related Documents

- [483 - 2023-05-11](https://www.keypedia.com/records/483/isovac-products-llc/08e71862-4c09-4487-ad1c-6cea124926d5)

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

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