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# Nephron Sterile Compounding FDA-483
- URL: https://www.fdaweb.com/nephron-sterile-compounding-fda-483/
- Published: 2022-06-07T12:00:00.000Z
- Updated: 2026-09-14T17:47:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151990

FDA has released the FDA-483 issued to Nephron Sterile Compounding Center, a West Columbia, SC, outsourcing facility, with seven observations from a 3/28-4/20 inspection. The specific observations were: 

- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch was already distributed;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to write and follow test procedures relative to appropriate laboratory testing for sterility;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process;
- all records of production and control associated with a batch of drug product were not maintained at \[redacted\] after the expiration date;
- laboratory records are deficient in that they do not include the initials and signature of the \[redacted\] person reviewing the record for accuracy; and
- the outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under Section 503B for two specified reasons.