# FDA 483 - Medidenta International Inc - November 05, 2025

Source: https://www.keypedia.com/records/483/medidenta-international-inc/a10a3a8a-3758-4a70-8787-214824533ea4

> FDA 483 for Medidenta International Inc on November 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medidenta International Inc
- Inspection Date: 2025-11-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Medidenta, a medical device manufacturer in Las Vegas, Nevada, was inspected and cited for significant deficiencies in its quality system. The inspection revealed failures to adequately establish and follow procedures for servicing activities and to maintain complete service records for its AW25C and AW30C Autoscalers. Additionally, the firm failed to establish adequate procedures for device history records, lacking documentation to demonstrate devices were manufactured according to the device master record and met specifications.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/medidenta-international-inc/b085e9af-c295-4d6e-92ed-1040a790820b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b