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FDAnews Drug Daily Bulletin

Washington State Compounder Cited for Unsafe Practices

June 28, 2017

A June FDA inspection left a Washington state pharmacy and compounder with a Form 483 citing unsafe production practices that could lead to drug contamination.

Shiraz Specialty Pharmacy in Mountlake Terrace, Wash., which does business as Axis Pharmacy Northwest, handled both highly potent drugs and beta-lactam-containing antibiotics without providing adequate containment and segregation, nor sufficient cleaning of work surfaces, utensils and personnel to prevent cross contamination, the 483 said.

All of the drugs the company produced were made in a non-sterile processing area without adequate controls to prevent contamination, including non-dedicated tools used in drug production for products ranging from penicillin to testosterone to mouthwashes. Moreover, investigators wrote, the firm did not conduct tests of compounded drugs to ensure there is no cross-contamination with beta-lactam antibiotics, which were handled in the same space.

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