FDA 483 - Sciteck Diagnostics - June 03, 2026

Sciteck Diagnostics in Fletcher, NC, was inspected by the FDA from June 1-3, 2026, and received a Form 483 with three observations. The inspection revealed significant deficiencies in record-keeping, production controls, and document control within their quality management system. Specifically, the firm failed to identify test equipment in production records, lacked documented procedures for critical manufacturing and monitoring activities, and did not properly control essential documents like Instructions for Use and batch records.