483
Recibio Inc.FDA 483 - Recibio Inc.
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Record Details
Recibio Inc. in Richmond, TX, a device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed a lack of quality audits and incomplete documentation for the design control of their Class II CeaLogic Specimen Collection Kit. These issues indicate failures in ensuring proper design review, verification, and validation processes.
- Company
- Recibio Inc.
- Product Type
- Device
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ID · 1c5facca-7fe8-45f0-b178-c2c5fe54ca23