483
Amerisource Health Services LLCAmerisource Health Services LLC – FDA 483, Nov 20, 2026
Record Details
An FDA inspection of American Health Packaging in Columbus, OH, revealed two significant observations. The firm failed to adequately validate cleaning procedures for shared packaging equipment, creating a risk of cross-contamination between different repackaged drug products. Additionally, the company's procedures lacked defined yield limit criteria, which prevented the objective evaluation of batch validity and suitability for release.
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ID · 8045720f-0837-434f-af76-24e3e1195ed9
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