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# FDA-483 on IntegraDose Inspection
- URL: https://www.fdaweb.com/fda-483-on-integradose-inspection/
- Published: 2025-08-28T12:00:00.000Z
- Updated: 2026-09-14T15:20:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159782

FDA has released the form [FDA-483](https://www.fda.gov/media/188467/download?ref=fdaweb.com) issued following a 7/15-7/25 inspection at IntegraDose Compounding Services, a Minneapolis, MN, outsourcing facility. The form’s six inspection observations were:

- failure to write and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to have statistical quality control criteria to include appropriate rejection levels;
- employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
- aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
- failure of laboratory records to include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness; and
- the quality control unit lacks the responsibility to approve all procedures or specifications affecting the identity, strength, quality, and purity of drug products.