FDA 483 - Sanofi Winthrop Industrie - July 19, 2016

This FDA Form 483 document details multiple observations from an inspection.

**Observation 1:** The firm repeatedly refused to provide requested documentation for CBER and CDER regulated products, including planned and unplanned maintenance records for tanks and skids, and initial/most recent requalification for sterilization of tanks. Incomplete documentation was also provided for Field Alerts.

**Observation 2:** The firm demonstrated a lack of thorough understanding of Field Alert submission requirements. Since March 2014, 58 Field Alerts were submitted, many originating from unconfirmed single consumer complaints. Examples include complaints for product failure where the sample was confirmed functional by QC, and instances where final Field Alert documents were not provided. Additionally, Field Alerts were not always submitted within the required 3-day timeframe.

**Observation 3:** Written complaint records did not include reasons for not conducting investigations into unexplained discrepancies. This includes failure to investigate visual particulates found in retain samples, and 291 "Difficult to Issue" complaints without conclusive root causes or quantitative review of stopper properties. A complaint investigation was also cancelled without adequate justification.

**Observation 4:** Investigations were found inadequate. Two media fill failures on a fill line isolated the same organism, Chaetomium subaffine, classified as "lowest risk" despite mold recovery from various swabbed areas, including uncontrolled storage. The firm lacked data to support the decontamination efficacy of a implemented (b)(4) cycle for filling equipment. Environmental monitoring