FDA 483 - Ranier's Compounding Laboratory - April 22, 2016

The FDA Form 483 details numerous violations observed during an inspection of a facility performing aseptic manipulations. Technicians were observed not practicing good aseptic technique, including donning sterile gloves inside the ISO 5 hood immediately prior to processing, vigorously shaking product with a gloved finger covering the stopper, and introducing nonsterile components without disinfection. Components were staged in a manner that disrupted first air flow, and non-sterile trash bags were placed against the HEPA filter face panel. Technicians did not sanitize hands after touching non-sterile components. Opened syringes were removed from the ISO 5 hood for verification.

The facility lacks proper sterilization and quality control measures. Biological indicators are not used to verify sterilization of Medroxyprogesterone Ophthalmic Suspension 1%. Endotoxin challenges are not performed to verify glassware sterilization. Endotoxin testing is not performed on water used in sterile drug product manufacturing. Media fills are not performed under stressful conditions and lack sufficient detail.

Environmental monitoring is insufficient: surface monitoring is only performed bi-weekly, not daily; glove tips are monitored bi-weekly, not after each operation; and non-viable particulate and viable air counts are performed bi-weekly, not daily. Pressure gauges are not continuously monitored, and there is no gauge between the ISO 7 Ante Room and the uncontrolled environment. A sporicidal agent is not used for cleanroom disinfection. A non-sterile spray bottle containing sterile water was used inside the ISO 5 area, and non-sterile wipes