FDA 483 - The Wellness Pharmacy - May 16, 2017

This FDA Form 483 document details observations made during an inspection concerning drug preparation and equipment cleaning practices.

**Facility and Operation Details:** The document refers to the preparation of hormonal BI-EST cream, specifically mentioning an instance on May 10, 2017, involving Rx (b)(4) and BI-EST Cream (9:1) of (b)(4) pursuant to (b)(4).

**Violations and Observations:** 1. **Utensils potentially absorptive or additive:** A rubber spatula was used for mixing hormonal BI-EST cream. These spatulas are cleaned with tap water and soap and reused. Discolored spatulas were observed in the drawer, indicating potential absorption or degradation. The spatulas are not dedicated to specific product types (e.g., hormonal vs. non-hormonal). This raises concerns about the purity, identity, or strength of the drug product being altered. 2. **Inadequate equipment and utensil cleaning:** Equipment and utensils are not cleaned appropriately to prevent contamination. On May 10, 2017, a technician was observed cleaning the (b)(4) of an (b)(4) after producing BI-EST Cream (9:1). The document notes that the (b)(4) are direct, implying a direct contact surface that requires thorough cleaning to prevent cross-contamination.

**Regulatory Citations and Requirements:** The observations suggest non-compliance with regulations