Delta Pharma, Inc. – FDA 483, Feb 23, 2017

The FDA Form 483 details numerous deficiencies at an unnamed facility producing injectable drug products.

**Sterilization and Depyrogenation Validation:** * The firm failed to validate the sterilization process for non-sterile (b)(4) used in finished injectable products. * The cleaning and sterilization process for (b)(4) of finished injectable drug products was not validated. * Sterilization processes for non-sterile wipes, sponges, and mop heads used in ISO 5, 7, and 8 areas, including their reuse, were not validated. * Sterilization (b)(4) for (b)(4) used in injectable drug production were not validated. * The depyrogenation process for (b)(4) sodium chloride (NaCl) using an (b)(4) was not validated. * Depyrogenation (b)(4) using an (b)(4) for finished product containers (amber glass vials) and glassware were not validated. * The cleaning process for glassware using household dish soap was not validated.

**Aseptic Processing and Environmental Control:** * Media fills were not performed by all operators, nor did they simulate actual processing conditions (e.g., largest batch size, all manipulations). * Post-production (b)(4) repeatedly failed to meet manufacturer specifications, with no investigations performed, and batches released (e.g., Benadram lot