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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Eugia US LLC is recalling two more injectable products in US for failed impurities, degradation specifications.
Four lots of Dexamethasone Sodium Phosphate injection is being recalled for out of specification (OOS) results of sulfonic acid adduct of dexamethasone phosphate impurity and one lot of Eptifibatide injection is being recalled for impurity Eptifibatide dimer above specifications. The medicines are manufactured by Eugia Pharma Specialities Limited, India
This marks the 6th recall by Eugia in last six months in this year (2024). Eugia had earlier recalled Nicardipine Hydrochloride Injection, Methylprednisolone acetate Injectable Suspension, Tobramycin for Injection, Methocarbamol Injection for issues like particulate matter and failed impurities during the year.
USFDA inspection of different Eugia facilities in India in year 2024 had observed serious discrepancies in operations and laboratory controls. The major deviations observed during USFDA audits include Data Integrity issues like updating records without actually performing the activities, Inadequate OOS investigations, Poor aseptic operations and operator practices, Inadequate process simulation studies and validation of aseptic processes, Inadequate cleaning and disinfection of equipment and accessories.
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