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# 3 Observations on SKNV Outsourcing FDA-483
- URL: https://www.fdaweb.com/3-observations-on-sknv-outsourcing-fda-483/
- Published: 2025-04-01T12:00:00.000Z
- Updated: 2026-09-14T14:56:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158933

FDA has released the form FDA-483 issued following a 2/13-3/6 inspection at SKNV, a Pompano Beach, FL, outsourcing facility. The three inspection observations were:

- failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
- failure to provide adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination in the production of hazardous drugs; and
- failure of the container of the facility’s drug products to include information required by law.