# FDA 483 - Ultrasonic Services, Inc. - December 10, 2021

Source: https://www.keypedia.com/records/483/ultrasonic-services-inc/23dd2e98-eb36-449f-a117-1510650547bc

> FDA 483 for Ultrasonic Services, Inc. on December 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultrasonic Services, Inc.
- Inspection Date: 2021-12-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Ultrasonic Services, Inc. in Houston, TX, was inspected and received a Form FDA 483 with seven observations, many of which were repeat findings. The inspection revealed significant deficiencies across its quality system, including a complete lack of quality system procedures, uninvestigated complaints, missing device history records, and inadequate control over service reports, incoming products, suppliers, and equipment calibration. These issues indicate a severe breakdown in the firm's ability to ensure the quality and safety of its reconditioned/refurbished Class II medical devices, specifically Ultrasonic Dental Scalers.

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/ultrasonic-services-inc/98e5eba6-7f8f-4bbb-b29c-311bc86ebfb7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab