# FDA 483 - Nephron Sterile Compounding Center LLC - July 06, 2016

Source: https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/a4b6bb27-ee2b-4bf2-b568-9a790c9e736a

> FDA 483 for Nephron Sterile Compounding Center LLC on July 06, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nephron Sterile Compounding Center LLC
- Inspection Date: 2016-07-06
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of NEPHRON PHARMACEUTICALS CORPORATION in West Columbia, SC, a sterile drug manufacturer, identified five significant deficiencies. These included inadequate laboratory record-keeping, insufficient employee training, and failures in documenting test method accuracy and process control deviations. The findings indicate a moderate level of non-compliance with good manufacturing practices, particularly concerning quality control and data integrity.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/constance-y-fears/0a19ee3b-1800-4e19-99d5-951d6252f8a7)
- [Narong Chamkasem, Chemist](https://www.keypedia.com/people/narong-chamkasem-chemist/4d659b1b-cc28-46c0-83d9-4ebb0b986fc9)
- [Director of Inspection Readiness](https://www.keypedia.com/people/bonita-s-chester/cc6ce6f4-bb5c-452a-820c-3339361bc8b2)
- [Postelle Birch-Smith, CSO](https://www.keypedia.com/people/postelle-birch-smith-cso/dcf2fe1a-5fde-4624-b81f-15bd859a5f45)
- [investigator](https://www.keypedia.com/people/larry-k-hampton/de10767b-b25b-4d55-bfe2-60ea51c828f6)

Company: https://www.keypedia.com/companies/nephron-sterile-compounding-center-llc/b9848542-bf88-4696-80c3-5fc545b76a92

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7