FDA EIR - Fisher Clinical Services, Inc. - August 31, 2017

Fisher Clinical Services, Inc. in Allentown, PA, was subject to an FDA complaint follow-up inspection on August 31, 2017. Conducted under the CPGM CP 7356.002B framework for Drug Re-packagers and Re-labelers, the inspection addressed allegations of Good Manufacturing Practice (GMP) issues. These concerns arose from a partial roof collapse and subsequent positive microbiological testing results within the facility. The inspection confirmed that a storm on July 1, 2017, led to roof damage and water intrusion. A "new" section of the primary packaging area exhibited water incursion and failed microbiological testing in a hallway, which was consequently sealed off for ongoing cleaning. Although no finished product was impacted by water in the warehouse, and an "old" packaging section showed acceptable microbial levels, the company decided to operate certain "old" primary packaging suites "at risk" for specific products, managing these activities through documented change controls and planned deviations to production holds. Notably, the FDA did not issue a Form FDA 483, and the complaint was closed, indicating no formal regulatory observations requiring new corrective actions from the agency, as the firm was already managing the identified issues internally.