Galaxy Surfactants Limited – FDA 483, Mar 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