The company has had to recall products and close down its drug repackaging plant, Heartland Repack Services, following the fifth quality control failure by the firm in 11 years. Omnicare has been compelled to issue seven product recalls since June 2006.
Although the firm had begun corrective action prior to the FDA issuing its warning letter, the agency felt that the document had to be sent "because corrective actions have not yet been completed, and because [the] firm's compliance history (including inspections in 1996, 1997, 2004 and 2006 that documented [current good manufacturing practice (cGMP)] deficiencies and multiple recalls resulting from poor cGMP controls), the serious nature of the observed violations, and the significant risk to consumers associated with…product contamination and product mix-up."
One of the major downfalls by the company was its failure to ensure that control systems were in place to prevent contamination or mix-up of products. Specifically highlighted was Omnicare's lack of separation of penicillin from non-penicillin drug products in the packaging plants, particularly dangerous given that around one in fifty people are allergic to penicillin.
Several cases of contamination and product confusion were noted by the FDA, put down to inadequate storage arrangements, poor employee training, and failure to establish and follow written guidelines, among other faults.
In one example, different strength formulas of the same drug were stored immediately adjacent to each other, resulting in 0.125mg tablets being included in the repackaging of 0.25mg tablets. Further lack of control measures on the packing line resulted in drugs being packed in the wrong boxes, and the labelling on the box therefore not matching the contents. The company was forced to recall the product lots.
Omnicare informed the FDA of measures it was taking to address the issues raised by the agency, which include hiring outside consultants to re-evaluate cGMP controls and retrain employees on cGMP, hiring new experienced QC/QA and plant managers and permanently relocating the drug repackaging operations to a new facility.
The said it was working with the FDA to tackle the issues raised in the warning letter.
"The deficiencies in your quality control systems were serious," the FDA correspondence informed the company.
"We remain concerned about the quality control systems and procedural problems that have allowed these significant deficiencies to remain unresolved for so long."
The firm provides pharmaceutical products to 1.4 million nursing home and healthcare patients across 47 states, and the quality violations outlined by the FDA could pose a serious risk to those patients.
As one last point to drive the message home, the FDA points out in its warning letter that "until FDA confirms correction of the deficiencies observed during the most recent inspection, [the] office can recommend disapproval of any new applications listing [the Omnicare site] as a manufacturer of drugs."
According to sources at Omnicare, the decision to shut down the Heartland site and relocate to a new facility was made easier by the fact that the lease for the repacking was due to expire shortly anyway. They were unable to comment on when the new facility would be up and running.
In the mean time, the company has been using packing facilities at some of it other sites to meet capacity and fulfil customer requirements.
"The company is going to do what it has to do to meet the customers' needs." a source at the firm told In-PharmaTechnologist.com.