FDA 483 - Positive Promotions - February 07, 2025

Positive Promotions, an OTC drug repackager and relabeler in Hauppauge, NY, received a Form FDA 483 with five observations. The firm was cited for failing to establish written procedures for production and process controls, including equipment qualification and supplier reliability validation. Additionally, deficiencies were noted in quality control unit procedures, batch record documentation, and employee GMP training, indicating a lack of adherence to current Good Manufacturing Practices.