FDA 483 - Laboratorios Labocont Industrial SRL - June 05, 2017

Labocont Industrial SRL, a human drug and OTC manufacturer in Santo Domingo, Dominican Republic, was inspected by the FDA. The inspection revealed significant deficiencies across its manufacturing processes for OTC ointment products, including a lack of written procedures, process validation, stability studies, and proper maintenance of critical systems. Furthermore, the firm failed to validate analytical methods, maintain complete batch and laboratory records, ensure equipment cleanliness, and provide adequate GMP training to employees.