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

This FDA Form 483, issued to Auro Pharmacies, Inc. in La Habra, CA, a producer of sterile and non-sterile drug products, details observations from an inspection conducted between July 9, 2018, and August 2, 2018.

Key observations include: 1. **Dirty Aseptic Processing Areas:** ISO 5 classified hoods used for sterile drug production had visible brown and white residue on HEPA filters and surfaces, despite daily cleaning claims. 2. **Inadequate Microbial Contamination Response:** The firm continued sterile drug production despite viable air monitoring samples in ISO 5 hoods exceeding action levels consecutively in January, February, and March 2018, without implementing corrective actions. 3. **Deficient Media Fills and Hold Time Data:** Two media fill failures (October 2016, March 2018) occurred, but sterile product processing continued without corrective actions. Additionally, there was no hold time data for depyrogenated vials, sterilized stoppers, and wipes stored in ISO 7 and ISO 8 areas, and the validation study for hold times was inadequate. 4. **Inadequate Dynamic Certification of ISO-5 Areas:** Uni-directional airflow in ISO 5 classified areas was not adequately verified under operational conditions, with smoke studies being unrepresentative and showing airflow obstructions. 5. **Vermin in Adjacent Areas:** Ants