FDA WARNING_LETTER - San Up S.A. - July 18, 2013

On November 25, 2013, the FDA issued a Warning Letter to SAN UP S.A. following an inspection from July 15-18, 2013, which found their piston and ultrasonic nebulizers to be misbranded devices. The firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, specifically lacking mention of reporting adverse events to the FDA in their "Sistema de vigilancia, GC-E-08-22, Revision 3" procedure, violating 21 CFR 803.17.

Additionally, the inspection revealed numerous quality system deficiencies under 21 CFR Part 820 (Quality System regulation). These include: 1. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), with examples of CAPA forms closed before actions were completed and missing containment actions. 2. Failure to document CAPA activities and results (21 CFR 820.100(b)), evidenced by missing signatures/dates on CAPA reports. 3. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)), as their "Sistema de vigilancia" procedure did not designate a unit for complaint review or mention MDR reportability. 4. Failure of management to establish quality policy and objectives (21 CFR