# FDA 483 - Sonogage Inc - March 21, 2018

Source: https://www.globalkeysolutions.net/records/483/sonogage-inc/a508ce6b-f4aa-4ec4-adc5-d24709a9fe01

> FDA 483 for Sonogage Inc on March 21, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sonogage Inc
- Inspection Date: 2018-03-21
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Sonogage Inc, a medical device manufacturer in Cleveland, OH, revealed significant deficiencies in process control procedures. The firm failed to establish manufacturing instructions for its pachometer devices and lacked adequate internal QC testing procedures. These issues indicate a lack of control over critical manufacturing processes.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/sonogage-inc/507a083b-aae2-4afd-bd78-611513df43c5

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22