FDA 483 - Enclara Pharmacia Inc - June 06, 2016

An FDA inspection conducted at Enclara Pharmacia Inc., a producer of sterile drugs, from June 1 to June 6, 2016, identified significant deficiencies in their sterile manufacturing operations. The firm received a Form FDA 483, indicating observations of non-compliance with Current Good Manufacturing Practices (CGMP).

The main issues observed centered on inadequate control of aseptic processing environments. Specifically, the environmental monitoring system was found deficient, with no surface microbial monitoring or technician glove monitoring performed after sterile operations in ISO 5 areas. Additionally, non-viable particulate and viable air counts were not conducted during routine sterile operations, and air pressure differentials in ISO 7 and ISO 8 clean rooms were not continuously monitored.

Further observations noted deficiencies in cleaning and disinfection procedures; the disinfectant used in the ISO 5 hood was not sterilized prior to use, and non-sterile wipes were employed for cleaning. Lastly, personnel clothing was deemed inappropriate, as gowns, facemasks, goggles, and hairnets worn by operators in ISO 5 zones were not sterile. Enclara Pharmacia Inc. is required to implement comprehensive corrective actions to address these critical observations and ensure the sterility and quality of their drug products.