FDA 483 - Galaxy Surfactants Limited - March 30, 2018

This FDA Form 483 details observations from an inspection, highlighting deficiencies in the facility's quality control unit, analytical methods, stability studies, employee training, and equipment cleaning procedures.

**Quality Control Unit Deficiencies:** * SOP # QC029-01 for water sampling and testing lacks specifications for REDACTED water used in API manufacturing. * SOP # QC003-00 for finished goods release was not followed; a non-USP, non-validated method (OCN_USP) was used to release multiple batches of REDACTED (e.g., Lot # REDACTED) between 2/17/2018 and 3/5/2018. * The process validation report (PVR/OCN-Retro/00) omitted critical parameters, including manufacturing instructions for Stages REDACTED and the REDACTED blending stage, equipment identity for Stages REDACTED and blending, in-process specifications, and 53 out of REDACTED assay data points from Table 18.3.

**Analytical Method Validation Issues:** * The GC method GQM 157, used for stability studies of API, REDACTED, is neither a USP nor an internally validated method. * Forced degradation studies using GQM 157 are incomplete. * A non-validated HPLC method was used for forced