COMPANY ALLOWED CONTAMINATION OF STERILE DRUG PRODUCTS, FDA SAYS

The FDA warned Abraxis Bioscience for distributing pharmaceuticals that could have been contaminated during manufacture and for marketing drugs without approved new drug applications.

During an inspection last summer, FDA investigators found several deviations from current good manufacturing practice regulations for finished pharmaceuticals, making Abraxis' products adulterated, according to the letter, sent Dec. 18, 2006, and posted to the FDA's website Feb. 16.

Abraxis responded to the agency's Form 483 in August 2006, but the deficiencies require more timely and comprehensive corrections than the ones suggested in the company's response, the FDA said.

The company failed to follow procedures to prevent contamination of its sterile drug products, the letter said. In its response, Abraxis said it would finalize a plan to validate all sterilizations by the end of 2008, which is too late, according to the FDA letter.

In addition, Abraxis did not conduct thorough and accurate investigations to determine the root causes of the product contamination, the letter said. The company investigation concluded that the contamination was isolated to two lots, but that conclusion was based on inaccurate and insufficient data, the agency said.

Abraxis did not respond to a request for comment by press time.

The warning letter can be seen at www.fda.gov/foi/warning_letters/g6218d.pdf ( http://www.fda.gov/foi/warning_letters/g6218d.pdf ).