FDA WARNING_LETTER - Delta Laboratories Pty Ltd - March 31, 2017

The FDA inspected Delta Laboratories Pty. Ltd. from March 27-31, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm failed to investigate release and stability testing failures (viscosity, appearance, packaging defects like tube swelling) for two batches of (b)(4) drug products. Investigations were inadequate, lacking root cause analysis and effective CAPA. A customer recalled an affected batch on November 28, 2017. 2. **Inadequate written procedures for production and process control (21 CFR 211.100(a)):** Manufacturing processes for (b)(4) drug products were not shown to be consistent and reliable, lacking adequate process validation studies. A retrospective analysis of a single batch, which itself had stability failures, was insufficient. The firm admitted a lack of understanding for consistent quality while still commercially distributing products. 3. **Inadequate stability testing program (21 CFR 211.166(a)):** The firm lacked sufficient stability data for (b)(4) drug products over their labeled expiry. Two lots distributed to the U.S. failed stability tests (viscosity, phase separation), with no appropriate action taken.

The firm's April 1