FDA 483 - Viva Pharmaceutical Inc - January 10, 2020

Viva Pharmaceutical Inc, an OTC drug manufacturer in Richmond, received a Form 483 with 14 observations following an FDA inspection from January 6-10, 2020. The observations highlight significant deficiencies across various quality system elements, including inadequate method validation, data integrity issues with electronic records, and insufficient written procedures for production, process controls, and cleaning. The findings indicate a broad lack of adherence to cGMP requirements, particularly concerning documentation, validation, and control of manufacturing processes and data.