THE US Food and Drug Administration (FDA) has sent a warning letter about manufacturing practices at NSW-based Delta Laboratories, in relation to its facility in Somersby, near Gosford.
Following a five-day inspection last Mar, the FDA found a number of defects including a failure by Delta to thoroughly investigate release and stability testing failures in two batches of a drug product.
"For example, you found tubes swelling at the 3-month stability time point. You did not investigate this significant defect, which can be indicative of microbial growth and spoilage," the letter said.
In addition, the FDA said Delta "lacked adequate process validation studies, did not have adequate stability data and failed to provide an adequate response to the agency on taking corrective actions to bring operations into full compliance".
Despite admitting struggling with manufacture of the product, items continued to be commercially distributed to consumers, with the FDA saying the findings indicate Delta's quality unit is "not fully exercising its authority".
The FDA recommended that Delta employ a qualified Current Good Manufacturing Practice (CGMP) consultant to address the violations and until they are corrected it may withhold approval of any new applications or supplements listing Delta as the manufacturer.
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