FDA 483 - Sharp Packaging Services, LLC - September 21, 2022
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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.
ID · 131ffb10-4021-427f-b3d6-d567ff906c4c