# Medco Manufacturing – FDA 483, Apr 9, 2026

Source: https://www.keypedia.com/records/483/medco-manufacturing/03941b6c-6017-4b1a-bc1a-46887c9bc534

> FDA 483 for Medco Manufacturing on April 09, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medco Manufacturing
- Inspection Date: 2026-04-09
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Medco Manufacturing, LLC in Spring, TX, a manufacturer, specification developer, and repackager/relabeler, revealed deficiencies in their risk management processes. The firm failed to adequately document risk assessments, specifically regarding the hazard of excessive (b)(4) and the appropriate severity rating for contamination risks. These issues indicate a significant concern with the firm's ability to identify and assess potential patient harm.

## Related Documents

- [483 - 2023-09-07](https://www.keypedia.com/records/483/medco-manufacturing/cb3c5732-6230-4272-8d2e-8f817de4dce7) — date: September 7, 2023
- [483 - 2019-05-13](https://www.keypedia.com/records/483/medco-manufacturing/169f1268-3768-4c03-8a25-97687271beb3) — date: May 13, 2019

## Related Officers

- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/medco-manufacturing/3dbeb100-78b8-4035-9c32-dc9b63391793

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9