FDA Warns Australian Firm for GMP Violations

The FDA hit Australian drugmaker Delta Laboratories with a warning letter for significant violations, including unreliable manufacturing processes, flawed stability testing and a lack of stability data.

An agency inspection of the company’s Somersby, New South Wales facility revealed that the firm failed to investigate stability testing failures of two product batches, and failed to initiative corrective and preventive actions for product quality failures.

The investigator also noted inconsistent and unreliable manufacturing processes that likely resulted in batches of inconsistent quality, purity and strength. The firm’s process validation studies were inadequate, and lacked documented evidence.