FDA 483 - Miramar Cosmetics, Inc - August 31, 2022

Miramar Cosmetic Inc, a dietary supplement distributor in Doral, FL, received eight observations during an FDA inspection. The firm demonstrated significant deficiencies, primarily a widespread lack of written procedures for critical operations including quality control, packaging, labeling, holding, distribution, handling returned products, and investigating complaints. Additionally, the inspection noted issues with untrained personnel and the failure to collect required reserve samples.