483
Sharp Packaging Services, LLCSharp Packaging Services, LLC – FDA 483, Sep 12, 2025
Record Details
Sharp Packaging Services, LLC in Macungie, PA, a human drug repacker, was cited with two observations during an FDA inspection. The firm failed to follow its written procedures regarding equipment cleaning and maintenance, specifically lacking documentation for re-cleans and personnel involved. Additionally, the firm did not ensure adequate training documentation for temporary employees engaged in primary product packaging operations.
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