Auro Pharmacies, Inc DBA Central Drugs – FDA 483, Dec 2, 2016

This FDA Form 483 details numerous deficiencies at a facility manufacturing sterile drug products, specifically Ascorbic Acid 500mg/ml.

**Sterilization and Aseptic Processing Deficiencies:** * Inadequate validation of the sterilization process, with process simulations (media fills) being insufficient. Simulations used different materials, had shorter operational times, did not represent actual batch sizes, and lacked proper inspection procedures for vials. * Growth promotion testing for incubated vials used unknown organism amounts. * Failure to perform dynamic smoke studies for ISO 5 laminar flow hoods. * Deficient environmental monitoring, including inadequate monitoring of pressure differentials, lack of non-viable particulate monitoring during filling, and no justification for alert/action limits or sampling sites. * Room (b)(4) was not qualified to meet ISO 5 and ISO 7 conditions. * No sporicidal agent used in ISO 5 laminar flow hoods. * Re-use of old sterile (b)(4) bottles for new (b)(4) without sterility assurance.

**Personnel and Gowning Issues:** * Inappropriate clothing for personnel, with exposed eye areas observed directly in front of ISO 5 hoods during filling and cleaning. * Unqualified operators gowned in ISO 7 area assisting with manufacturing and environmental monitoring. * Personnel repeatedly moving between ISO 7 and ISO 8 rooms without following gowning procedures.