ASPIRO PHARMA SPECIALITIES PRIVATE LIMITED – FDA 483, Jun 16, 2026

Aspire Pharma Specialities Private Limited, a sterile drug manufacturer in Karkapatla, India, received a Form 483 citing significant deficiencies in their manufacturing processes. Observations included inadequate aseptic process validation, deficient equipment maintenance in aseptic areas, and a systemic failure to investigate discrepancies and manage alarms effectively. These issues raise serious concerns about the quality and sterility assurance of their drug products.