Mistakes include distribution of batch of Levothyroxine Sodiumtabletslabelled as being 1000 times stronger than they were. The US Food and Drug Administration (FDA) notes four separate incident reports linked to mislabelling but, despite this, the Agency says Shamrock Medical was slow to react.
Proposals to restrict technicians’ access to the master labelling program, which was the cause of the errors, were sent to the quality unit at Shamrock Medical on March 31, 2011. “To date, your firm has not reported any corrective or preventive actions taken to address these violations,” the FDA wrote.
FDA inspectors visited the repackaging facility in Ohio in August and issued a 483. Shamrock Medical sent a response on May 17 but, as it was received more than 15 days after the 483, the FDA ignored the comments when considering sending a warning letter. A warning letter was sent two weeks ago.
The FDA will consider the May 17 comments alongside any responses to the warning letter. Exclusion of the 483 responses means it is possible Shamrock Medical has addressed the concerns but, at the time of writing the warning, the FDA repeatedly noted a lack of corrective or preventive actions.
FDA inspectors criticised Shamrock Medical for distributing products containing air bubbles or with low fill volumes. The failings were blamed on a lack of written procedures for manual repackaging of liquid drugs and, because of the late response to the 483, the FDA had no evidence of improvements.
A slow response and shortcomings at the quality assurance unit also combined on another violation noted by the FDA. The quality unit was criticised for releasing Diltiazem HCl 120mg extended-release capsules that were mislabelled as 250mg after it failed to follow its review and approval procedures.