483
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA 483, Sep 19, 2023
Record Details
AstraZeneca Pharmaceuticals LP in Mount Vernon, IN, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in following written procedures for in-process controls, specifically regarding tablet weight assessment and handling out-of-specification results. Additionally, laboratory records were found to be deficient due to inadequate control and retention of analytical worksheets.
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ID · 588ae947-ca3a-4174-83f6-d54fc5ae8752
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