FDA 483 - Teligent Pharma, Inc. - May 20, 2019

Teligent Pharma, Inc. in Buena, NJ, a drug manufacturer, was cited for significant deficiencies across its quality control, production, and quality systems. The inspection revealed failures in rejecting out-of-specification drug products, inadequate investigations into stability failures, widespread issues with laboratory and production records, and non-adherence to stability testing programs and complaint handling procedures. Additionally, the firm failed to submit required NDA Field Alert Reports and complete annual product reviews, indicating systemic control issues.