FDA 483 - Kobo Products, Inc - August 18, 2020

Kobo Products Inc. in South Plainfield, NJ, was inspected and cited for significant deficiencies across its laboratory, production, and quality systems. The firm failed to establish and document test method accuracy, maintain adequate computer controls for data integrity, and ensure complete laboratory records. Additionally, critical manufacturing operations lacked proper controls, quality unit responsibilities were not consistently followed, and no written stability testing program existed for OTC drug products.