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# FDA Releases RC Outsourcing FDA-483
- URL: https://www.fdaweb.com/fda-releases-rc-outsourcing-fda-483/
- Published: 2020-07-14T12:00:00.000Z
- Updated: 2026-09-14T16:20:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147196

FDA has just released the FDA-483 issued following a 1/14-2/8/19 agency inspection at RC Outsourcing, Lowellville, OH. The eight inspection observations were: 

- failing to follow written production and process control procedures in the execution of production and process control functions;
- failing to have a written testing program designed to assess the stability characteristics of drug products;
- failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed;
- testing and release of drug product for distribution procedures do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release;
- failing to establish and document the accuracy, sensitivity, and reproducibility of test methods;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to conduct specific identification tests on components that have been accepted based on the supplier’s report of analysis; and
- the facility compounds drugs that are essentially a copy of one or more approved drugs.