# FDA 483 - Ovesco Endoscopy Usa, Inc. - May 22, 2025

Source: https://www.keypedia.com/records/483/ovesco-endoscopy-usa-inc/ecb7731e-f6a2-46d0-bdb5-46a0e3dcacb9

> FDA 483 for Ovesco Endoscopy Usa, Inc. on May 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ovesco Endoscopy Usa, Inc.
- Inspection Date: 2025-05-22
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Ovesco Endoscopy Usa, Inc. in Cary, NC, a manufacturer of medical devices, was cited with three observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning inadequate procedures for equipment calibration, quality audits, and management review. These issues indicate a lack of robust controls over critical manufacturing and quality assurance processes.

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Company: https://www.keypedia.com/companies/ovesco-endoscopy-usa-inc/353ed913-afaa-4e02-84cd-baed3bcaa66d

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