The USA’s Abraxis Bioscience has received a stern warning from federal regulators about manufacturing procedures at one of its facilities which it says fail to “prevent microbiological contamination of drug products purporting to be sterile and failure to validate sterilisation processes.”
The US Food and Drug Administration has published a letter it sent to Abraxis in December complaining about conditions at its plant in Melrose Park, Illinois and therefore “the company is in violation of federally enforced manufacturing standards.”
The problems were uncovered during an inspection of the plant between May and June 2006 and the letter is fairly damning about Abraxis’ response to the original warning. The FDA says that “you do not acknowledge any deficiencies in the investigation of these sterility test failures, and you provide no additional information to support the conclusion…that the contamination which led to the product failures was isolated.”
The agency goes on to say that in rare instances, it is acceptable to deem sterility failures of aseptically filled product as an "isolated event," but “ in the light of the significant problems you encountered with the control of the Melrose Park facility in 2005,” as well as during the current inspection, “our confidence in your investigative conclusion for the sterility failures…is further weakened.”
The letter also notes that Abraxis also has been marketing three injectable drugs – calcium chloride, levothyroxine sodium and vasopressin – without having FDA-approved applications, and orders the company to send the agency a plan of action for sorting out the problems within 15 days of receiving the letter.
Abraxis says it has now responded to the letter and voluntarily stopped shipping the three drugs mentioned above, although those treatments are among thousands of such drugs on the market that were not regulated by the FDA until recently.
- Meantime, Abraxis also noted that it has completed the acquisition of Pfizer’s Cruce Davila manufacturing complex in Barceloneta, Puerto Rico. The 56-acre site consists of a 172,000-sq-ft plant with capabilities of, among other things, producing injectables as well as protein-based biologics and metered-dosed inhalers. The firm expects to begin commercial manufacturing there in the first half of 2007.