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# Multiple Violations at Nephron Pharmaceuticals
- URL: https://www.fdaweb.com/multiple-violations-at-nephron-pharmaceuticals/
- Published: 2020-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:14:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146770

FDA has released the FDA-483 issued to Nephron Pharmaceuticals Corp., doing business as Nephron Sterile Compounding Center, West Columbia, SC, with nine inspection observations. The [document](https://www.fda.gov/media/137539/download?ref=fdaweb.com) lists these observations: 

- failing to write and follow test procedures relative to appropriate lab testing for sterility;
- failing to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to follow written procedures for sampling and testing plans for each drug product;
- aseptic processing areas are deficient in that the floors and walls are not smooth and/or hard surfaces that are easily cleanable;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failing to document established test procedures at the time of performance;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are initiated only by authorized personnel; and
- failing to thoroughly review any unexplained discrepancy whether or not a batch has been already distributed.