FDA 483 - Nephron Sterile Compounding Center LLC - April 20, 2018

This FDA Form 483 document details observations made during an inspection on April 16, 2018, concerning the manufacturing of drug products. The primary focus of the observations is the inappropriate clothing and practices of personnel engaged in drug manufacturing, specifically within sterile compounding areas.

A key observation notes that a sterile pharmacy technician in the ISO 7 area had their neck skin visibly exposed due to improper gowning. Although the technician went to the ISO 8 area to correct the gowning, they returned to the ISO 7 area after only spraying their gloved hands with a solution, without replacing the gloves. This raises concerns about potential contamination.

Furthermore, the safety goggles used by all sterile technicians and the supervising pharmacist in the ISO 7 compounding areas, including those working in ISO 5 laminar flow hoods, were observed to have features that "may allow contamination of the aseptic compounding area." This suggests a potential design flaw or inadequacy in the personal protective equipment used, which could compromise the sterile environment.

The observations indicate deficiencies in personnel gowning procedures and the suitability of personal protective equipment, both critical aspects of maintaining aseptic conditions in drug manufacturing.