# Marlen Manufacturing & Development Co. – FDA 483, May 6, 2026

Source: https://www.keypedia.com/records/483/marlen-manufacturing-development-co/7b0dfdb8-97f7-4b0e-9be3-26ac5a72f656

> FDA 483 for Marlen Manufacturing & Development Co. on May 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marlen Manufacturing & Development Co.
- Inspection Date: 2026-05-06
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Marlen Manufacturing & Development Co. in Bedford, OH, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation for process validation, production controls, and risk management processes. Additionally, the firm failed to enter required Unique Device Identification (UDI) numbers for its medical devices into the GUDID database.

## Related Documents

- [483 - 2022-06-08](https://www.keypedia.com/records/483/marlen-manufacturing-development-co/86f31766-dc6f-4ab8-8e52-6c8f16c6fdac) — date: June 8, 2022

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/marlen-manufacturing-development-co/e881f88e-5a3d-428f-9471-1ecbb901e25d

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22