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# Drug Outsourcing Firm Cited After Inspection
- URL: https://www.fdaweb.com/drug-outsourcing-firm-cited-after-inspection/
- Published: 2020-05-08T12:00:00.000Z
- Updated: 2026-09-14T16:14:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146750

FDA has cited RC Outsourcing (Lowellville, OH) for GMP issues after the drug outsourcing facility was inspected in February. For example, a just-posted [FDA-483](https://www.fda.gov/media/136444/download?ref=fdaweb.com) said the firm did not follow written production and process control procedures when executing production and process control functions. The investigator also said there is no written testing program designed to assess the stability characteristics of the company’s drug products. Additionally, RC Outsourcing failed to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, it failed to conduct an investigation into 70 syringe defect complaints the firm received between 4/1/2017 and 12/31/2018.