Outbreak-linked firm has had safety issues

Oct. 11, 2012 at 2:37 PM   |   Comments

BOSTON, Oct. 11 (UPI) -- Ameridose, the Boston-area pharmacy linked to an outbreak of fungal meningitis, has had questions about safety issues before, federal records indicate.

The company was cited for significant problems with production records, procedures and drug testing in 2008, The Boston Globe reported Wednesday.

An FDA inspector found Ameridose did not follow "expected" procedures for sterilization and quality assurance, did not test all its lots of drugs, and shipped some products before testing could determine if they were sterile, among other issues.

Shortly after that inspection, the company recalled 155 bags of the painkiller fentanyl because the doses were too potent.

Ameridose is owned by the same men who own the New England Compounding Center, which has been implicated as the source of the meningitis outbreak.

Ameridose on Wednesday voluntarily agreed to suspend operations until Oct. 22.

Neither the company nor Massachusetts state health officials have indicated that any Ameridose products were tainted or unsafe.

Officials from the FDA and the state health department say they plan to conduct a "comprehensive investigation" of both Ameridose and New England Compounding, including their corporate structures.

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