483
Practicon IncFDA 483 - Practicon Inc - February 26, 2026
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Record Details
Practicon Inc, a repackager/relabeler in Greenville, NC, was inspected and cited for significant deficiencies in its quality management system. The inspection revealed failures in maintaining records of risk management activities for its Class II medical device, the Practicon Acu-Tip Cauterizing Instrument. Additionally, the firm lacked adequate management review processes and failed to ensure necessary personnel competence through proper training.
- Office
- Atlanta District Office
- Person
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ID · cb609d8b-a3b0-46ba-baf8-cca860009453