# FDA 483 - Apollo Renal Therapeutics, LLC - September 11, 2019

Source: https://www.globalkeysolutions.net/records/483/apollo-renal-therapeutics-llc/3000cec5-8d27-45cd-b869-e70f24c02127

> FDA 483 for Apollo Renal Therapeutics, LLC on September 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apollo Renal Therapeutics, LLC
- Inspection Date: 2019-09-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Apollo Renal Therapeutics, LLC, a medical device contract manufacturer in Ocala, FL, revealed significant deficiencies in their quality system. Observations included inadequate process validation for medical products, undocumented equipment calibrations, and poorly established procedures for handling complaints and corrective and preventive actions. These issues indicate a need for comprehensive improvements in their manufacturing and quality control processes.

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/apollo-renal-therapeutics-llc/1c81cd31-d342-4b23-887f-c8ef3caa7625

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6