The warning letter, made public last week, highlighted several cases of deviation from current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals at the company's Melrose Park, Illinois site.
The run-down of charges covers various incidences of a lack of sufficient guidelines and procedures to prevent microbiological contamination of drug products, and failures on the part of the company to conduct adequate investigations following cases of contamination or sterility problems.
The FDA warning letter highlights that contamination with one particular organism, Bacillus pumilus, occurred nine times during 2006, and another case involved contamination with an organism commonly found on human skin, Propionbacterium acnes.
The FDA notes that the company's investigations into these, and other, sterility failures were inadequate and that the conclusions drawn by Abraxis were unsupported by accurate information.
"In light of the significant problems you encountered with the control of the Melrose Park facility in 2005 as well as the significant cGMP deviations documented during the current inspection, our confidence in your investigative conclusion for the sterility failures noted…is further weakened." the warning letter from the FDA read.
Among other contamination issues raised in the FDA letter, further charges related to misbranding and marketing of new drugs by Abraxis.
The company markets calcium chloride, levothyroxine sodium and vasopressin. The FDA notes that these drugs are classified as 'new drugs' as they are not generally recognized as safe and effective for their labelled uses. Under FDA regulations, a new drug "may not be introduced into or delivered for introduction into interstate commerce unless and FDA-approved application is in effect for the drug."
Based on FDA information, Abraxis BioScience possesses no such approval for the three products.
On top of this, the FDA also accused the company of misbranding the above drugs:
"Adequate directions cannot be written for these prescription drugs so that a layman can use them safely for their intended uses," the warning letter stated. As a result of this, the FDA claims the labelling fails to bear sufficient directions as required by the agency's regulations.
Failure to address the violations catalogued by the FDA could result in regulatory action being taken against the company. Until the FDA can confirm measures have been taken and the deficiencies noted during the most recent inspection have been corrected, the agency can recommend disapproval of any new applications listing the Melrose Park site as a manufacturer of drugs.
No one from the company was available for comment.
Meanwhile, Abraxis last week announced that it had completed the acquisition of Pfizer's manufacturing facility in Puerto Rico. The Barceloneta manufacturing plant is EU and US compliant for the production of injectable pharmaceuticals, as well as protein based biologics and metered-dose inhalers.
The facility also comprises a 90,000 square foot active pharmaceutical ingredient (API) manufacturing plant and two support facilities. The acquisition provides a third site for the production of the company's breast cancer drug, Abraxane (paclitaxel protein-bound particles for injectable suspension). The company expects commercial manufacturing to begin at the start during the first half of 2007.