US drug repackager receives a warning letter from the US FDA
Shamrock Medical Solutions Group, a drug repackager based in Lewis Center, Ohio, US, has received a warning letter from the US FDA after inspectors identified violations to cGMP regulations.
An inspection carried out between 3–24 August 2011 found that the firm’s processes did not meet cGMP standards and ‘adulterated and misbranded drugs’ entered the supply chain.
The FDA said Shamrock failed to exercise appropriate controls over computer systems to ensure that ‘changes in master production and control records, or other records are instituted only by authorised personnel’.
The inspectors found that repackaging technicians changed master labels of Levothyroxine Sodium, Diltiazem HCI ER Capsule, and Metoclopramide, which resulted in product packages being labelled with the incorrect strength or the incorrect spelling of the drug name. These mislabelled packets were then released for distribution.
Although Shamrock proposed to revise the labelling system software to restrict technicians’ access to the master labelling programme on 31 March 2011, ‘to date, your firm has not reported any corrective or preventive actions taken to address these violations’, the FDA said.
In addition, the FDA said Shamrock did not have any written procedures for the manual repackaging of liquid drugs into oral syringes or fluid dose cups, nor did it have a process to ensure that the repackaged containers are properly filled.
Consequently, the firm received complaints from customers that products contained air bubbles and had low fill volumes.
The firm also failed to conduct all required in-process sampling and weight checks, nor did it include yield calculations, or identify who performed or verified yield calculations for batch production records for several lots of various drug products that were repackaged and released.
The FDA said it had reviewed Shamrock’s response on 23 August 2011 to these production failings, but said it lacked sufficient corrective actions.
Although the firm sent a written response to the FDA on 17 May 2012, because it was received more than 15 business days after Form FDA 483 was issued, the FDA said the response had not been considered.
‘We plan to evaluate your response to the Form FDA 483, along with any other written material provided, as a direct response to this warning letter,’ the FDA said.