FDAnews Drug Daily Bulletin

Wockhardt Gets Another FDA Warning Letter Over GMP Deficiencies

Dec. 1, 2016

CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations.

At CP Pharmaceuticals’ UK plant, FDA inspectors witnessed multiple operators touching surfaces and items in the ISO-7 clean area and failing to disinfect their hands before performing activities in the ISO-5 area. Investigators also noticed bags with sterile supplies coming in contact with non-sterile instruments in the ISO-7 area when being transported to the restricted access barrier systems.

The inspection also uncovered that the firm’s environmental monitoring programs did not sufficiently cover personnel in the ISO-5 area during set-up, filling, and other activities in the aseptic processing rooms.

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