# Consolidated Research, Inc. DBA General Sleep Corporation – FDA 483, Mar 25, 2026

Source: https://www.keypedia.com/records/483/consolidated-research-inc-dba-general-sleep-corporation/9aedde4e-a793-4c89-a920-d3c3890a8e93

> FDA 483 for Consolidated Research, Inc. DBA General Sleep Corporation on March 25, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Consolidated Research, Inc. DBA General Sleep Corporation
- Inspection Date: 2026-03-25
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Consolidated Research, Inc., a medical device manufacturer in Euclid, OH, received a Form FDA 483 with seven observations highlighting significant deficiencies in its quality management system. Key issues include inadequate risk management, failure to implement and document corrective actions for recurring device failures, poor record-keeping for rework activities, and insufficient supplier evaluation and monitoring. Additionally, the firm lacks a quality manual and has incorrect Unique Device Identifier (UDI) information submitted to the FDA.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)
- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/consolidated-research-inc-dba-general-sleep-corporation/afd70f6a-73ec-41d4-b27f-7a4704ceca09

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