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483
•Ceragroup Industries Inc•October 11, 2022

FDA 483 - Ceragroup Industries Inc - October 11, 2022

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Record Details

Ceragroup Industries Inc, a medical device manufacturer of dental porcelain powders and pastes in Fort Lauderdale, FL, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, equipment calibration, management review procedures, and supplier evaluation. These issues indicate a lack of adequate control over critical manufacturing processes and quality management.

Company
Ceragroup Industries Inc
Inspection Date
October 11, 2022
Product Type
Device
Office
Office of Medical Device and Radiological Health Division II
Person
  • Stanley B. Eugene (investigator)
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ID · b6f0cd71-0f60-4cfd-9ee6-d7e44eb7cd75

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