Pharmathen International S.A.

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 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)).

Passage 2

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 3

Your firm did not adequately investigate out-of-specification (OOS) and out-of-limit (OOL) results. Your investigations of sterility failures and significant environmental monitoring excursions lacked adequate scientific rationale to support root causes and implementation of effective CAPA.

Passage 4

Your firm did not implement effective CAPA to reduce recurrence of severe contamination hazards including, but not limited to, operator error that had contributed significantly to recurring sterility and media-fill failures over the past five years.

Passage 5

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 6

Your firm failed to document at the time of performance required laboratory control mechanisms and to record and justify any deviations from required laboratory control mechanisms (21 CFR 211.160(a)).