# FDA 483 - Stonegate Pharmacy LP - August 09, 2019

Source: https://www.keypedia.com/records/483/stonegate-pharmacy-lp/c948dd31-de1a-4498-9261-c32c51948cfd

> FDA 483 for Stonegate Pharmacy LP on August 09, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stonegate Pharmacy LP
- Inspection Date: 2019-08-09
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

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## Related Officers

- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

Company: https://www.keypedia.com/companies/stonegate-pharmacy-lp/f7c2ae1a-3694-4030-b0f7-b37e0794a48d

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9