FDA 483 - Raining Rose, Inc. - February 07, 2025

Raining Rose Inc., a non-sterile OTC drug manufacturer in Cedar Rapids, IA, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate pest control, widespread issues with laboratory controls and data integrity, a deficient Quality Control Unit, and poor equipment management and calibration practices. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices.