Wockhardt Gets Another FDA Warning Letter Over GMP Deficiencies
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.
In the letter, the FDA noted that the firm has repeatedly failed to create a robust monitoring program as a previous inspection in 2010 revealed many of the same concerns.
CP Pharmaceuticals responded to the letter, but the agency states that the firm failed to perform a risk assessment, sufficiently monitor all personnel conducting aseptic activities in the ISO-5 area and failed to describe any details of how the assessment will be conducted.
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