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Medical Devices / Inspections and Audits

FDA Swats Lannett for Quality Control, Batch Production Issues

May 9, 2018

The FDA hit Lannett Company with a Form 483 for quality control procedures and batch production and control record shortcomings.

The agency cited its Seymour, Indiana facility, which it inspected in February 2018, for having deficient batch and control records. Not all records included documentation of each step in packing.

In addition, the firm did not open investigations for all low level complaints within their 45-day deadline as required by a standard operating procedure.

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