483
Legacy Pharmaceutical Packaging LLCLegacy Pharmaceutical Packaging LLC – FDA 483, Apr 27, 2022
Record Details
Legacy Pharmaceutical Packaging, LLC. in Earth City, MO, received an FDA Form 483 for significant deficiencies in its operations. The inspection revealed inadequate production and process controls, including unvalidated reprocessing procedures and incomplete batch records. Furthermore, the firm failed to ensure proper employee training and conducted insufficient investigations into batch failures and product contamination.
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ID · 75edfb0b-91b7-433b-8a62-206fbce3b285
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