# FDA 483 - Nephron Pharmaceuticals Corp. - August 17, 2012

Source: https://www.keypedia.com/records/483/nephron-pharmaceuticals-corp/20ae3bb3-aeb8-4dc3-a617-03709efbc605

> FDA 483 for Nephron Pharmaceuticals Corp. on August 17, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nephron Pharmaceuticals Corp.
- Inspection Date: 2012-08-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Nephron Pharmaceuticals Corp., an aseptic fill drug manufacturer in Orlando, FL, was cited for three observations during an FDA inspection. Deficiencies included the quality control unit not following procedures for annual product reviews and field alert reports, inadequate line clearance activities, and a failure to conduct routine re-qualification training for analytical lab employees. These issues indicate a lack of adherence to established written procedures across multiple operational areas.

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## Related Officers

- [Angela Glenn](https://www.keypedia.com/people/angela-glenn/5ba5e1e2-883b-42c4-aae0-3564820723e8)
- [Charles R. Cote](https://www.keypedia.com/people/charles-r-cote/f6975cde-470e-4e86-bf1a-0337dcf5a367)

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