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FDAnews Drug Daily Bulletin

Unsanitary Issues Lead to Warning Letter for Morton Drug Company

Dec. 7, 2016

The Morton Drug Company has received a warning letter following FDA investigators witnessing unsanitary conditions at its plant.

The compounder was inspected over a week in December 2015. Investigators observed significant deficiencies when it came to producing sterile drug products.

Investigators noted that the firm did not monitor pressure differentials between the clean room and ante room and observed operators cleaning the ISO 5 hood with non-sterile cleaning agents while wearing street clothing. In addition, Morton’s pharmacy technician had their hair, arms, face, and neck exposed to sterile pharmaceutical products while cleaning the ISO 5 hood.

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