FDA 483 - ImprimisRx CA, Inc., dba ImprimisRx - July 02, 2014

The FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing injectable drug products.

**Observation 1** highlights a deficient environmental monitoring system in aseptic processing areas. Specifically, active viable air monitoring is not performed daily in the ISO 5 hood during production, and surface monitoring of ISO 5 hood surfaces is not conducted at the end of each production day. Microbiological monitoring of filling technician fingertips is also not performed daily. Furthermore, the environmental monitoring program lacks non-viable particulate monitoring during injectable drug product filling.

**Observation 2** notes that personnel clothing is inappropriate for their duties in drug product processing.

**Observation 3** identifies inadequate validation of the sterilization process in procedures designed to prevent microbiological contamination. The Aseptic Technique Personnel Validation is deficient because not all filled vials are incubated, the validation does not represent the maximum bulk product volume filled during routine operations, a minimal amount of sterile media is used, and it does not simulate lyophilizer loading in the ISO 7 buffer area.

**Observation 4** states that each batch of sterile drug product is not laboratory tested for conformance. Suitability testing for the sterility test method has not been performed by the contract testing laboratory for products such as Calcium chloride 100mg/ml, Zinc Sulfate Preservative Free Injection, and Inositol 50mg/ml Solution Injection.

**Observation 5** indicates that stability testing results are not used to determine expiration dates, specifically for