# FDA 483 - Nephron Pharmaceuticals Corp. - May 18, 2010

Source: https://www.keypedia.com/records/483/nephron-pharmaceuticals-corp/94431a50-bfc4-4de9-8ac7-fe5cce232257

> FDA 483 for Nephron Pharmaceuticals Corp. on May 18, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nephron Pharmaceuticals Corp.
- Inspection Date: 2010-05-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Nephron Pharmaceuticals Corp. in Orlando, FL, a drug product manufacturer, revealed significant issues across three observations. The firm's quality control unit lacked proper oversight for approving procedures and specifications impacting drug product quality, particularly concerning microbiology lab results. Additionally, drug product containers were not stored to prevent contamination, and the facility's clean rooms were not maintained in good repair, showing rust and a lack of monitoring for such conditions.

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## Related Officers

- [Kimberly M. Hull](https://www.keypedia.com/people/kimberly-m-hull/dd9a4388-b2e8-4782-ae47-1b4cb5de35c0)

Company: https://www.keypedia.com/companies/nephron-pharmaceuticals-corp/0f5ad323-e857-47f3-adcf-4e39f1f62408

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