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# Multiple Violations at Cantrell Drug Company
- URL: https://www.fdaweb.com/multiple-violations-at-cantrell-drug-company/
- Published: 2016-11-10T12:00:00.000Z
- Updated: 2026-09-14T21:46:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137317

FDA has released the FDA-483 from a 9/14-10/14 Dallas District Office inspection at Cantrell Drug Co., an outsourcing facility, showing 12 violations. Specific inspection observations were: 

- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failing to establish, write, and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
- separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products;
- failing to write and follow test procedures relative to appropriate laboratory testing for sterility and pyrogens;
- failing to have a written testing program designed to assess drug product stability characteristics;
- failing to have testing and release of drug product for distribution include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient before release;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
- the building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, labeling, in-process materials, and drug products, and to prevent contamination;
- failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
- labels of the facility’s drug products are deficient; and
- failing to record and justify deviations from written production and process controls.