# FDA 483 - Sciteck Diagnostics - June 03, 2026

Source: https://www.keypedia.com/records/483/sciteck-diagnostics/adb9b70c-e138-48f6-a485-25ab6967eeeb

> FDA 483 for Sciteck Diagnostics on June 03, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sciteck Diagnostics
- Inspection Date: 2026-06-03
- Product Type: device
- Office Name: Atlanta District Office
- Summary: 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.

## Related Officers

- [Benjamin E. Bowen](https://www.keypedia.com/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.keypedia.com/companies/sciteck-diagnostics/3b8343d1-fac8-427e-a095-e9f55f79b292

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7