FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

FDA Hits Morton Salt with Form 483 for Cleaning, Manufacturing Violations

Jan. 11, 2017
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Morton Salt was handed a Form 483 after an inspection revealed inadequate cleaning procedures and faulty manufacturing equipment.

FDA investigators cited Morton’s facility in Texas in August for four observations, involving the facility’s oversight of the packaging room, sterility practices, as well as its equipment maintenance and qualification.

The document states that the company’s quality assurance manager claimed the packing area was clean, but agency investigators discovered standing pools of water and pieces of brown and grey semi-solid material within five feet of bagging equipment.

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