FDAnews Drug Daily Bulletin

Sanitation, Labeling Lapses Bring Warning Letters for Two Compounding Facilities

Oct. 25, 2016

Two compounding facilities have received warning letters for violations in the manufacturing process.

When investigators inspected U.S. Specialty Formulations, based in Bethlehem, Pa., they found that drug products that were intended or expected to be sterile were prepared, packed or held under insanitary conditions and may have been contaminated.

Investigators also observed that some Specialty Formulations drug products did not include certain information on their labels, including dosage form and strength of the drug, storage and handling instructions and a list of inactive ingredients.

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