Eugia Pharma Specialities Limited

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).

Passage 2

You failed to ensure adequate environmental monitoring (EM) of classified areas used for aseptic production. For example, you did not hold extended ISO 5 areas of processing line **(b)(4)**, where critical aseptic connections occurred, to ISO 5 limits.

Passage 3

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).