# FDA 483 - Indilab, Inc. - February 09, 2026

Source: https://www.keypedia.com/records/483/indilab-inc/5a362ef7-70fd-4981-a696-c63e65e9321f

> FDA 483 for Indilab, Inc. on February 09, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Indilab, Inc.
- Inspection Date: 2026-02-09
- Product Type: device
- Office Name: FDA District Office — Chicago, Illinois
- Summary: Indilab, Inc. in Franklin Park, IL, a manufacturer of medical devices, was cited with two observations during an FDA inspection. The inspection revealed inadequate planning and control in product design and development, specifically concerning process qualification for their Indistrip Steam Indicator. Additionally, the firm's Medical Device Reporting (MDR) procedure was found to be deficient, lacking proper documentation and recordkeeping requirements for reports and recall information submitted to the FDA.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/indilab-inc/f9eaad19-45e3-4ded-a668-1baa2bebbc52

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65