FDA EIR - Caldic USA Inc - May 11, 2018

An FDA inspection of Avatar Corporation, a manufacturer and repackager of active pharmaceutical ingredients (API), food, and cosmetic ingredients located in University Park, IL, occurred from May 8 to May 11, 2018. This routine inspection, conducted under FDA Compliance Program Guidance Manuals 7356.002F, 7371.001, and 7356.002B, primarily focused on the firm's drug manufacturing operations, including API production (specifically Petrolatum) and the blending/repackaging of USP excipients such as Mineral Oil and Glycerin. The inspection comprehensively evaluated key operational systems, including Quality, Facilities & Equipment, Materials, Production, Packaging & Labeling, and Laboratory Controls. Specific areas reviewed involved complaint management, investigations, change controls, validation processes, personnel training, maintenance records, batch documentation, equipment calibration, and out-of-specification (OOS) procedures. Crucially, the inspection concluded without revealing any significant objectionable observations, and no FDA Form 483 was issued to the company. This positive outcome indicates the facility's adherence to regulatory requirements during the inspection period. All observations from a prior inspection in 2016 had been previously verified as corrected. Therefore, no new corrective or preventative actions were mandated by the FDA as a direct result of this May 2018 inspection.