FDA EIR - Glatt Air Techniques, Inc. - November 05, 2018

An FDA inspection of Glatt Air Techniques, Inc., a contract pharmaceutical manufacturer in Ramsey, NJ, was conducted from October 25 to November 5, 2018. This Good Manufacturing Practice (GMP) inspection, under Compliance Programs 7356.002 (Drug Manufacturing) and 7371.001 (Animal Drug Manufacturing), focused on the Quality and Laboratory Control Systems. Notably, no Form FDA 483, Inspectional Observations, was issued during this inspection. The report confirmed that the company had successfully addressed all three deficiencies identified during a previous inspection in January 2017. These prior issues included inadequate cleaning and sanitization of equipment, insufficient quarantine procedures for drug products, and failures in routine checking of electronic stability monitoring equipment. Glatt Air Techniques implemented new Standard Operating Procedures, enhanced monitoring, and conducted verification studies, which were all deemed adequate. During the closeout meeting for the 2018 inspection, management acknowledged two verbal observations. First, documentation was lacking for a chemist's training on a specific stability testing method. Second, an investigation into environmental monitoring excursions was not thoroughly extended to evaluate the microbiological content of manufactured drug products. Management committed to performing corrective actions to address these points. This inspection concluded without any formal written observations or sample collections, indicating overall compliance with regulatory expectations despite the verbal concerns raised.