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# FDA Posts 7-item Form 483 for U.S. Specialty Formulations
- URL: https://www.fdaweb.com/fda-posts-7-item-form-483-for-u-s-specialty-formulations/
- Published: 2017-09-15T12:00:00.000Z
- Updated: 2026-09-14T22:50:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139639

FDA has issued a [seven-item Form 483](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm576143.pdf?ref=fdaweb.com) after inspecting U.S. Specialty Formulations last month. According to the just-posted document, the firm was cited for personnel gowning for aseptic operations in non-classified areas, and the gowning area is not supplied with HEPA-filtered air. The investigator also was troubled by aseptic processing areas being deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Additionally, the inspection found that equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination.