An Ohio CMO has been slapped with a warning letter from the FDA this month chastising the company for its manufacturing practices and failure to report any corrective or preventative actions.
During an August 2011 inspection of Shamrock Medical's Lewis Center, OH, facility, FDA regulators discovered "significant" violations of current good manufacturing practice (cGMP), notably the mislabeling of more than three types of prescription drugs, including Levothyroxine, Diltiazem and Metoclopramide. According to the warning letter, misprints resulted from Shamrock repackaging technicians changing the master labels. In March 2011, Shamrock promised to restrict technician access to the company's master labeling program, but failed to follow through, the warning letter says.
Other violations the FDA cited include Shamrock failing to have written procedures for the manual repackaging of liquid drugs and quality control. Customers have also complained about Shamrock regarding poor packaging practices and low-fill volumes, according to the letter.
As Outsourcing-Pharma details, the FDA has filed four separate incident reports against the CMO in the past. A phone call from FierceCRO to Shamrock Medical seeking comment was not returned by deadline.
- here's the warning letter
- get more from Outsourcing-Pharma