Teligent Pharma, Inc. – FDA EIR, Oct 19, 2017

An FDA inspection of Teligent, Inc. in Buena, NJ, conducted from October 2 to October 19, 2017, identified significant deficiencies in its manufacturing operations. This surveillance, Good Manufacturing Practice (GMP), and pre-approval inspection, falling under established drug manufacturing and pre-approval guidelines, uncovered critical issues. Under GMP, the company failed to handle raw materials to prevent contamination, specifically noting the use of Polyethylene Glycol containing bag remnants in Lidocaine Ointment production without adequate investigation. For pre-approval applications, the inspection highlighted inadequate or absent investigations into manufacturing failures, such as uninvestigated low product yields and unresolved packaging integrity issues. Other pre-approval concerns included the lack of structural identification for out-of-specification impurities, failure to verify microbiological methods, not testing finished products to updated specifications, and a general lack of adherence to and scientifically sound establishment of laboratory control mechanisms and product specifications. Teligent, Inc. management received a six-point FDA-483 form detailing these observations and is required to submit a written response outlining their corrective actions within 15 business days.