Nephron Sterile Compounding Center LLC – FDA 483, Nov 15, 2019

The FDA Form 483 details multiple deficiencies at a pharmaceutical facility.

**Sterility Testing and Procedures:** * Rapid sterility test procedures are inadequate: "background too high" samples (verbally defined as >X events) are discarded and product lots are released without investigation. This occurred ~23 times in 90 days. * No written definition of "background too high" or instructions for discarding/retesting. * Poor aseptic technique observed during sample preparation (e.g., passing hands over open containers). * No eye exam requirement for analysts reviewing rapid sterility results. * Analysts conducted commercial sterility testing before demonstrating ability to identify positive microbial events (e.g., one associate performed tests from Oct 3-29, 2019, but only saw a positive example on Oct 29). * No documentation of start/stop/elapsed incubation times for rapid sterility tests; only temporary notes on tape that are discarded.

**Aseptic Processing and Environmental Control:** * Failure to follow SOP.CM.4102 (Aseptic Processing and Technique): * Operator observed opening Luer Lock IV Syringe Cap containers directly over cap scoop, blocking first air, and touching feeder with gloved hand. * Operators sanitized gloved hands *before* personnel monitoring. * Operator moved rapidly within ISO-5 Clean Room, causing tote and glo