FDA Issues 483 for Leading Pharma’s Storage and Testing Conditions

August 19, 2016

A generics drugmaker has netted a host of operational performance citations over conditions at one of its plants.

A March inspection of Leading Pharma’s facility in Fairfield, N.J., revealed deficiencies in the firm’s established test procedures, records and final inspection of drug products before distribution, according to a three-citation Form 483.

FDA inspectors found that the facility failed to maintain adequate written records and conduct proper follow-up reviews on conditions at its warehouses. For instance, even though the receiving and shipping warehouses for finished drug products and APIs have encountered temperature fluctuations over the past year, the facility failed to perform a formal investigation.

Additionally, the facility did not adhere to established test procedures. Inspectors said the facility failed to test purified water used in manufacturing furosemide tablets and glycopyrrolate tablets for water conductivity.

Finally, inspectors faulted the firm for failing to test all product batches to ensure uniformity and integrity of products before distribution.

The 483 also complained that Leading Pharma neglected to investigate unknown peaks in stability data.

The inspection was conducted between February and March.

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