FDA Cites Facility for Aseptic Processing Violations

November 28, 2016

Wockhardt Limited received a warning letter from FDA for CGMP violations.

On Nov. 16, 2016, FDA sent a warning letter to Wockhardt Limited regarding current good manufacturing practices (CGMP) violations observed at the company’s CP Pharmaceuticals facility, located in Wrexham, United Kingdom. The violations were primarily related to poor aseptic processing practices.

FDA investigators inspected the facility in October 2015 and found that the company failed to follow written procedures set up to prevent microbiological contamination of sterile products. Specifically, personnel were observed performing activities in cleanrooms without first disinfecting their hands, and equipment was not properly disinfected prior to use. The agency also stated that the company’s quality unit did not catch or document the deviation.

The agency also stated in the letter that the company had failed “to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas.” The company’s environmental monitoring program failed to monitor certain personnel in ISO-5 areas, and the restricted area barrier system was not adequately disinfected.

FDA recommended the company obtain an aseptic processing consultant and perform an evaluation of the design, control, and maintenance of the company’s aseptic processing lines. The agency asked the company to perform a risk assessment of the potential effects of the violations on product and create an overall management strategy for overseeing operations.

Source: FDA