The FDA has been making its way through inspections of the country's largest compounders and has found issues with Option Care, which was formed last year when Walgreens ($WBA) sold its infusion care services to a private equity group. The service is recalling nearly three dozen products after two inspections of its Option Care compounding operations in Texas were found to be short on sterility precautions.
The recall includes 33 products ranging from saline and dextrose, to heparin, insulin, vancomycin, milrinone and compounded Remicade. It comes after inspections last year and in 2014 that found a host of problems at the Dallas facility that call into question the sterility of the products made at compounding center. The first inspection came before Walgreens sold control of the business to Madison Dearborn Partners of Chicago for an undisclosed sum, keeping a "significant minority interest" for itself.
According to the Form 483s, there were some problems with airflow in the ISO rooms and a lack of stability testing for products including Dextrose 5% and 0.9% Sodium Chloride 3000 mL, as well as the hospital antibiotic Cubicin, that Option Care had manufactured. An inspector saw aseptic manufacturing problems like masks that did not fully cover workers' faces and one worker who reused a sterile glove that had been dropped on the floor. In a warehouse that sits adjacent to the manufacturing area, an inspector saw "what appeared to be hundreds of dead insects throughout."
The FDA assumed more oversight of the compounding industry in 2014 with the passage of the Drug Quality and Security Act. The new requirements were put in place after a fatal outbreak of fungal meningitis was tracked back to unsterile conditions at the compounding facility where it was produced. Since the agency started inspecting compounding pharmacies, dozens have been required to recall all of their sterile products in response to issues the FDA uncovered.
One of those was Dallas-based Downing Labs, which found itself in deeper problems last week. The FDA reported that a federal court had issued a consent decree against the compounder, its owners and lead pharmacist. It claimed the compounder had continued to manufacture adulterated drugs even after repeated warnings about sterility issues.
Some companies see opportunities in the shortcomings of the compounding industry. AmerisourceBergen ($ABC) laid out $2.575 billion last fall to get its hands on PharMEDium Healthcare Holdings, a large national compounding operation, while QuVa was formed in August with a capital infusion from Bain Capital. QuVa's Temple, TX, compounding facility was one of the first to receive an Establishment Inspection Report, which it said recognized its "effort to not only meet, but to exceed FDA standards."
- the recall notices can be found here
- read the 2015 Form 483
- here's the 2014 Form 483