FDA EIR - Fisher Clinical Services Inc. - January 10, 2018

Fisher Clinical Services Inc. in Mt. Prospect, IL, a contract packager and manufacturer of investigational human drug products for clinical trials, underwent a comprehensive FDA inspection from December 18, 2017, to January 10, 2018. The inspection was conducted under established compliance programs for Drug Manufacturing, Drug Repackagers and Relabelers, and Import for Export Domestic Follow-Up, reflecting its role in handling investigational new drug (IND) clinical trial products. This inspection aimed to verify compliance, particularly assessing the company's resolution of five observations issued during a previous inspection in October-November 2015. These prior issues included inadequate procedures for tracking internal complaints, restricted access for the Director of Quality to controlled storage, insufficient routine review of facility environmental data, inconsistent adherence to a specific status review procedure, and physical infrastructure problems like damaged production doors and unaddressed differential pressure failures. During the 2017-2018 inspection, all previously identified issues were confirmed as voluntarily corrected by the company. The inspection covered the Quality, Production, and Packaging and Labeling Systems. No significant deficiencies were identified, and consequently, no Form FDA 483 (Inspectional Observations) was issued to the firm. Management was reminded of their responsibility to adhere to the Food, Drug, and Cosmetic Act.