# FDA 483 - Panoramic Corp. - August 07, 2019

Source: https://www.keypedia.com/records/483/panoramic-corp/cff28173-402c-40ed-b563-df78c894a1d0

> FDA 483 for Panoramic Corp. on August 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Panoramic Corp.
- Inspection Date: 2019-08-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Panoramic Rental Corp., a medical device manufacturer of dental x-ray machines in Fort Wayne, IN, was cited with three observations during an FDA inspection. The firm failed to adequately establish procedures for design change, corrective and preventive actions, and risk analysis. These issues, including repeat observations, indicate significant deficiencies in their quality system.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/panoramic-corp/737d4017-26bf-4229-92de-eedfc6773452

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0