FDA 483 - Stonegate Pharmacy LP - August 09, 2019

An FDA inspection on July 30, 2019, revealed multiple violations at a facility producing sterile and non-sterile drug products.

**Gowning and Aseptic Technique Deficiencies:** * A pharmacy technician failed to cover exposed skin (forehead and eyes) while producing sterile drug products in an ISO 5 laminar airflow hood, allowing these areas to enter the sterile environment. Products affected include Chorionic Gonadotropin, Testosterone Cypionate (Grapeseed Oil), and Testosterone USP (Ethyl Oleate) solutions. * The same technician reused non-sterile booties multiple times throughout the day for sterile production, storing them on the anteroom floor. Sterile gown drawstrings contacted these reused booties and entered the sterile environment. * Non-sterile gowns were reused for "approximately REDACTED to REDACTED days" or "until they get really dirty" in non-sterile production areas. A reused gown was used for Methylcobalamine/Methionine/Inositol/Choline Rapid Dissolve Tablets.

**Containment and Cross-Contamination Issues:** * The entry door to the REDACTED area, used primarily for hazardous hormone-containing drug products, was propped open with napkins during production of Methylcobalamine/Methionine/Inositol/Choline Rapid Dissolve Tablets. This negative pressure area's door had fallen twice without risk assessment or maintenance records. The area is adjacent to drug product storage and non