FDA 483 - Auro Pharmacies, Inc. - August 02, 2018

This FDA Form 483 was issued to Auro Pharmacies, Inc. in La Habra, CA, a producer of sterile and non-sterile drug products, following an inspection from July 9 to August 2, 2018. The inspection revealed ten observations related to quality system and manufacturing issues.

Key observations include: 1. **Dirty Aseptic Processing Areas:** ISO 5 classified aseptic processing areas, specifically laminar flow hoods used for sterile drug production, had visible brown and white residue on HEPA filters and surfaces. This was observed on multiple hoods (Hoods #1, #2, #3, #4, #5) and air supply vent covers for ISO 7 classified air, despite claims of daily cleaning. 2. **Inadequate Microbial Contamination Response:** The firm failed to adequately evaluate and take remedial action for actionable microbial contamination in ISO 5 classified aseptic processing areas. Viable air monitoring samples exceeded action levels consecutively in January, February, and March 2018, but sterile drug production continued without corrective and preventive actions. 3. **Deficient Media Fills:** Media fills did not adequately simulate aseptic production. Two media fill failures occurred on October 6, 2016, and March 8, 2018, yet sterile product processing continued without corrective actions. Additionally, there was no hold time data for depyrogenated vials, sterilized stoppers, and wipes