FDA EIR - Sentry Biopharma Services, Inc. - June 29, 2021

An FDA routine surveillance inspection of Sentry Biopharma Services, Inc., located in Indianapolis, IN, was conducted on June 29, 2021. The inspection covered the company's operations as a drug warehouse, labeler/relabeler, and repacker. This comprehensive review was performed in accordance with compliance program CP 7356.002 for Drug Manufacturing Inspections, focusing on adherence to current Good Manufacturing Practices (cGMP). The inspection team thoroughly assessed key operational systems, including Quality, Facilities and Equipment, and Packaging & Labeling. All aspects reviewed, such as employee training, calibration and maintenance records for various temperature-controlled storage environments (ambient, refrigerated, frozen, ultra-low temperature), and procedures for handling controlled substances, were found to be satisfactory. Review of deviations, CAPAs, and change controls for 2018-2021 also revealed no significant concerns, with reported deviations primarily involving minor temperature excursions or shipping issues that were appropriately managed. Crucially, no objectionable conditions or significant issues were identified during the inspection. As a result, no FDA-483 Inspectional Observations Form was issued to Sentry Biopharma Services, Inc. The inspection was classified as "No Action Indicated" (NAI), signifying that the firm was found to be in compliance with regulatory requirements, and no corrective actions were required by the FDA.