FDA 483 - Eugia Pharma Specialities Limited - September 16, 2016

The FDA Form 483 details observations from an inspection of a facility manufacturing sterile human drug products, specifically "Injectable 8 mg 8 mL."

One critical observation is the failure to submit a Field Alert Report within three working days. The firm received six complaints between March and September 2016 for four batches of "Injectable 8 mg 8 mL," describing stoppers pushing into vials upon spiking. The firm's own investigation (Final Investigation Report dated September 1, 2016, and #PRD-INV-0001-16-00) confirmed the issue, rendering the product unusable, yet no Field Alert was filed.

Additionally, laboratory controls are deficient as written test procedures for assay and related substances for all sterile injectable drug products for the US market use 8 of unit containers in sample preparation for HPLC analysis, justified by reducing variability, which may not be scientifically sound.

Production and process controls lack adequate written procedures. Equipment qualification, specifically for the vial stoppering machine, is insufficient. Document #SHI0260Q Rev 1.0 and FU4-PN-001-EQP-PQ-002 do not include quantitative evaluation for products. During the inspection on September 7, a large number of product vials with dislodged and variable stoppers were observed during production of Injection (batch unspecified). Furthermore, re-qualification document FU4-PN