FDA EIR - Almacenes Generales De Deposito De Cafe S.A. AlmaCafe - April 02, 2019

An FDA inspection of Almacenes Generales De Deposito De Cafe S.A. AlmaCafe (AlmaCafe), a coffee green bean manufacturer, was conducted from April 1-2, 2019, in Bello, Antioquia, Colombia. The inspection assessed the firm's compliance with Title 21 CFR Part 117, covering Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. A significant issue identified was a deficiency in the firm's hazard analysis, specifically regarding the likelihood of Ochratoxin A (OTA) presence due to mold development from inappropriate storage conditions. AlmaCafe’s hazard analysis deemed this hazard "not likely," citing monitoring procedures. However, the FDA investigator found that the supporting study was outdated and lacked sufficient detail, and the firm's own complaint records indicated issues such as "fermented and mold" affecting coffee quality, directly contradicting their hazard assessment. This observation was issued on a one-item Form FDA 483, referencing 21 CFR 117.136(a)(2)(i) concerning corrective actions for preventive controls. AlmaCafe’s Plant Manager committed to addressing the observation and submitting a written response to the FDA within 15 working days. The FDA emphasized that failure to implement voluntary corrections could lead to legal sanctions, including import alerts.