FDAnews Drug Daily Bulletin

Three Compounders Cited for Adulterated Drugs and GMP Violations

Dec. 6, 2016

The FDA has sent warning letters to three compounders for failing to produce sterile drug products.

The Prescription Lab Compounding Pharmacy was inspected last year and investigators noted that the firm manufactured with domperidone, which is not a component of an FDA-approved human drug and the labeling of their products failed to bear adequate directions for their intended uses.

Stonegate Pharmacy was cited for several CGMP violations at its facility including inadequate systems for cleaning and disinfecting equipment and failing to establish and follow appropriate written procedures to prevent microbiological contamination of drug products.

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