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# 3 Observations on XeCare FDA-483
- URL: https://www.fdaweb.com/3-observations-on-xecare-fda-483/
- Published: 2026-09-10T12:00:00.000Z
- Updated: 2026-09-13T19:20:15.000Z
- Author: David McFarland
- Tags: enforcement, #legacy-id-D5161755

FDA has released the Form FDA-483 issued following a 6/8-6/17 inspection at XeCare, a New Albany, OH, producer of sterile and non-sterile drug products. The three inspection observations were:

- producing hazardous drugs without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination;
- exposing materials to lower than ISO 5 quality air; and
- using ingredients not intended for pharmaceutical use in non-sterile drug production.