API Maker Chided for Multiple Quality Lapses

September 21, 2014

Marcus Research Laboratory was handed a Form 483 for not performing stability testing or properly monitoring the production process for the active pharmaceutical ingredient iodine.

During a June inspection of Marcus’ St. Louis facility, the FDA found that from 2010 to 2014 the manufacturer missed scheduled stability testing for 23 lots of various types of iodine API.

The company’s quality unit also didn’t perform an annual product quality review for the entirety of 2013, said the form with nine observations.

In addition, the manufacturer did not monitor and record the temperature or humidity of a room where non-Cl Povidone undergoes its moisturizing phase to be used in the manufacture of povidone-iodine USP API.

“It has been determined that this phase is a critical step in the manufacturing process and will affect your final product,” said the FDA.

Marcus did not return a request for comment as of press time.

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