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# Nephron Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/nephron-pharmaceuticals-fda-483/
- Published: 2017-05-03T12:00:00.000Z
- Updated: 2026-09-14T22:21:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138606

FDA has released the FDA-483 issued at the conclusion of a 4/17-4/21 inspection at Nephron Pharamceuticals, West Columbia, SC. Specific violations noted on the [form](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm555311.pdf?ref=fdaweb.com) include: 

- failing to include adequate validation of the sterilization process in procedures designed to prevent microbiological contamination of a drug product purporting to be sterile;
- failing to include in laboratory controls the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to fully follow the responsibilities and procedures applicable to the quality control unit; and
- deficient container labels for the outsourcing facility’s drug products.