Sharp Packaging Services, LLC – FDA 483, Sep 21, 2022

Sharp Packaging Services, LLC in Allentown, PA, received a Form 483 following an inspection from September 19-21, 2022. The inspection revealed significant deficiencies related to the manufacturing of sterile products, including inadequate procedures for preventing microbiological contamination, insufficient sterilization process validation, and a lack of controls for electronic data acquisition systems. Additionally, the firm failed to establish adequate cleaning and decontamination procedures for product-contact equipment.