FDA 483 - Teligent Pharma, Inc. - October 18, 2017

Teligent, Inc. in Buena, NJ, was inspected and cited for multiple significant deficiencies in its manufacturing and laboratory controls. Observations included failures to prevent material contamination, inadequate investigations into product failures, unestablished microbiology test method suitability, and insufficient drug product testing and release procedures. Additionally, the firm failed to follow its own laboratory control SOPs and established scientifically sound specifications for drug products.