# FDA 483 - Nephron Pharmaceuticals Corp. - June 17, 2011

Source: https://www.keypedia.com/records/483/nephron-pharmaceuticals-corp/dd40d453-666f-4e51-85c7-7000f3aa817b

> FDA 483 for Nephron Pharmaceuticals Corp. on June 17, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nephron Pharmaceuticals Corp.
- Inspection Date: 2011-06-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Nephron Pharmaceuticals Corp. received a Form 483 citing multiple deficiencies across quality control, manufacturing, and laboratory operations. Key issues include inadequate investigations into sterility failures and out-of-specification results, untimely completion of annual product reviews, and failures in laboratory control mechanisms and instrument calibration. The firm also lacked proper stability testing programs, environmental monitoring in aseptic areas, and timely submission of Field Alert Reports for distributed drug products with significant changes.

## Related Documents

- [483 - 2010-05-18](https://www.keypedia.com/records/483/nephron-pharmaceuticals-corp/94431a50-bfc4-4de9-8ac7-fe5cce232257)
- [483 - 2012-08-17](https://www.keypedia.com/records/483/nephron-pharmaceuticals-corp/20ae3bb3-aeb8-4dc3-a617-03709efbc605)
- [483 - 2014-02-21](https://www.keypedia.com/records/483/nephron-pharmaceuticals-corp/e406463a-7f55-4e3b-ba70-d214fe456a85)
- [483 - 2015-08-14](https://www.keypedia.com/records/483/nephron-pharmaceuticals-corp/1f3c6d8f-027d-4fb8-a003-5135818d528c)

## Related Officers

- [Angela Glenn](https://www.keypedia.com/people/angela-glenn/5ba5e1e2-883b-42c4-aae0-3564820723e8)
- [Retired-FDA Compliance Officer, CDER](https://www.keypedia.com/people/carla-a-norris/90f059dd-f4cc-4599-b9c9-134465185c49)
- [sharon.thoma@fda.gov](https://www.keypedia.com/people/sharon-k-thoma/d72ee980-45a4-4f2c-9b1e-e29798492e7d)

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