FDA Inspection
Consolidated Research, Inc. DBA General Sleep CorporationConsolidated Research, Inc. DBA General Sleep Corporation – FDA Inspection, Mar 25, 2026
Record Details
This FDA Inspection record concerns Consolidated Research, Inc. DBA General Sleep Corporation, with an inspection on March 25, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
- Inspection Date
- March 25, 2026
- Product Type
- Medical Devices & Rad Health
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ID · ba3b35cf-5d37-4c26-96ac-65135a4c9a4a
Inspection Facts
- Inspection number
- 1309448
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
7- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.2.1Quality management system documentation not adequate
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 8.3.4Rework records not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Consolidated Research, Inc. DBA General Sleep Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Consolidated Research, Inc. DBA General Sleep Corporation
- FDA Inspection 1068333 - 2018-08-09
- FDA Inspection 817361 - 2013-02-07
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