FDA WARNING_LETTER - Clinicon Corp - April 04, 2019

The FDA issued a Warning Letter to Clinicon Corporation following an inspection from April 3-4, 2019, at their Oceanside, CA facility. The inspection revealed that Clinicon, a manufacturer and specification developer of SureProbe Class II sterile, single-use laser accessory probes, was operating in violation of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Process Validation (21 CFR Part 820.75(a)):** The firm lacked validation documentation for the SureProbe device packaging process and had not revalidated or reassessed the sterilization process since 2015, despite the standard requiring a formal assessment and requalification approximately every (b)(4) years. No package integrity testing was performed, and the development of the sealing procedure lacked protocol, acceptance criteria, test data, or a final validation report. The (b)(4) coating process for capillary tubing also lacked validation. 2. **Undocumented Equipment Calibration and Maintenance (21 CFR Part 820.72(a)):** The pneumatic heat sealer used for sterile packaging was not calibrated or maintained, despite manufacturer recommendations for (b)(4) calibration. 3. **Undocumented Supplier and Contractor Evaluation (21 CFR Part