Altaire Pharmaceuticals, Inc. – FDA EIR, Mar 9, 2017

An FDA inspection of Altaire Pharmaceuticals, Inc., a manufacturer of sterile prescription and over-the-counter ophthalmic drugs, was conducted from February 27 to March 9, 2017. This inspection served as a follow-up to previous deficiencies and a systems-based Good Manufacturing Practice (GMP) review, covering human and veterinary drug products under compliance programs 7356.002A, 7356.002, and 7371.001. The inspection identified several significant issues, resulting in five FDA 483 observations. Key violations included the failure to perform essential mechanical interventions during aseptic manufacturing simulations (media fills) and incomplete laboratory records, specifically regarding data from incubated media fill units. Furthermore, the company lacked scientifically sound and appropriate laboratory controls, evidenced by inadequate management of microbial isolates, issues with environmental monitoring media preparation, and ineffective trending of environmental monitoring data. Process validation deficiencies were noted, particularly concerning the establishment of process parameters and hold time studies for specific drug products. Finally, the inspection also found shortcomings in the trending of product quality complaints. These observations indicate a need for Altaire Pharmaceuticals to enhance its adherence to regulatory requirements for sterile drug manufacturing. Management acknowledged the observations, with some indicating retraining and procedural adjustments would be implemented.