FDA 483 - TSDR Pharmacy Inc. dba brandMD Skin Care - March 28, 2017

This FDA Form 483 documents observations from an inspection of a facility preparing drug products in a pharmacy room.

**Key Violations and Observations:**

1. **Inadequate Laboratory Controls:** * No specifications or test procedures for critical attributes of drug products prepared in the pharmacy room. * No assay specifications for any drug products. * No established test procedures for Color, Odor, Appearance, pH, and Viscosity tests for drug product release. * Homogeneity of prepared bulk drug products was not demonstrated.

2. **Absence of a Quality Control Unit (QCU):** * No QCU or designated person with responsibility and authority to approve/reject components, containers, packaging, labeling, and drug products. * SOP No. A-07, Compounding Quality Assurance, defines QCU responsibility but no QCU exists. * No procedures or quantitative analyses for potency testing of prepared drug products to support label claims. * Pharmacist-in-Charge (PIC) performs all drug preparation activities, and these activities are not reviewed or verified by a second person. * Completed Formulation and Batch Compounding Records (FBCR) are approved by the PIC himself, without review by an independent quality person. * Active Pharmaceutical Ingredients (APIs) (Hydrocortisone, Hydroquinone, Retinoic Acid/T