FDA 483 - People's Custom Rx and Clinical Care, LLC - July 29, 2015

From July 20-29, 2015, the FDA inspected People's Custom Rx and Clinical Care, LLC, a producer of sterile drug products in Memphis, TN. The inspection revealed nine observations regarding the firm's manufacturing practices and quality systems.

Observation 1 noted inadequate procedures to prevent microbiological contamination. A technician re-entered a clean room without changing garbing, non-sterile 99% Isopropyl Alcohol was used for sanitization, and non-sterile, reused gowning components were permitted.

Observation 2 cited deficiencies in environmental monitoring. Weekly air and surface monitoring was deemed inadequate, with insufficient sample points and infrequent monitoring of technicians' fingertips.

Observation 3 detailed issues with material flow, specifically the lack of decontamination for supplies and components before introduction into aseptic processing areas.

Observation 4 highlighted deficiencies in maintaining equipment for aseptic conditions. Smoke studies for ISO 5 hoods were not video recorded, documented, or performed under dynamic conditions, and pressure in controlled areas was only checked once daily.

Observation 5 identified a lack of validation for sterilization processes, including stock solutions, autoclaving rubber stoppers and finished drug products, depyrogenating/sterilizing glassware, and terminal sterilization of oil-based drug products.

Observation 6 reported issues with equipment calibration. A Boekel incubator for sterility samples was consistently out of range (25.2°C to 30.8°C vs. 22