483
Avara Liscate Pharmaceutical Services SPAFDA 483 - Avara Liscate Pharmaceutical Services SPA - December 06, 2022
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Record Details
An FDA inspection of Avara Liscate Pharmaceutical Services S.r.l. in Liscate, Italy, a contract drug manufacturer, revealed significant deficiencies in quality control and record-keeping. The firm failed to adequately investigate product complaints, out-of-specification deviations, and ensure the effectiveness of corrective actions. Additionally, the facility lacked proper microbiological control for equipment and maintained deficient batch production records.
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ID · 57ade3fa-5b27-4869-9303-934d3792b63d