Plantas Mexicanas de Exportacion GT S.A. de C.V. – FDA EIR, Nov 8, 2019

An FDA comprehensive surveillance inspection of Plantas Mexicanas de Exportación, S.A. de C.V. was conducted from November 6-8, 2019. This was the firm's first inspection under the new Preventive Control Regulations (21 CFR 117) for human foods. The inspection covered the manufacturer and labeler of bulk spices and herbal dietary ingredients, assessing their compliance with the Preventive Controls and Sanitary Human Foods Operations regulatory framework. Although no formal FDA Form 483 was issued, several verbal observations were made. Main issues included the inadequate placement of hand-washing stations in production areas, necessitating employees to traverse the entire warehouse, with only sanitizing gel available at workstations (21 CFR 117.37). The firm's hazard analysis initially failed to identify specific biological hazards (Clostridium Perfringens, Clostridium Botulinum, and Bacillus Cereus) (21 CFR 117.130(a)(1)), and their food safety plan did not explicitly list sanitation and employee GMP training as preventive controls (21 CFR 117.135(a)(1)). Furthermore, preventive control records lacked complete E. Coli analysis results and proper documentation of review by a Preventive Control Qualified Individual (PCQI) (21 CFR 117.305). The presence of adhesive tape on damaged raw material bags was also observed as a contamination risk (21 CFR 117.93), and chlorine level monitoring records for water lacked documented corrective actions for low readings. The company initiated voluntary corrections during the inspection for most observations, including updating their hazard analysis, food safety plan, and record-keeping processes, and sewing damaged bags instead of using tape. However, the issue of hand-washing station placement and complete chlorine monitoring record-keeping remained unaddressed with no immediate timeline for full resolution, though employee retraining was promised for the latter.