# FDA 483 - Vita Pharmacy, LLC dba Talon Compounding Pharmacy - August 03, 2018

Source: https://www.keypedia.com/records/483/vita-pharmacy-llc-dba-talon-compounding-pharmacy/4505cc95-198c-4e7a-b7f7-933fd269e9a9

> FDA 483 for Vita Pharmacy, LLC dba Talon Compounding Pharmacy on August 03, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Inspection Date: 2018-08-03
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection, highlighting multiple deficiencies in facility design, aseptic processing, quality control, and environmental monitoring.

**Facility and Operations:** The facility includes an ISO 7 cleanroom with an ISO 5 aseptic processing area and an ISO 8 anteroom. The firm aseptically compounds sterile patient-specific finished drug products.

**Violations and Observations:**

*   **Observation 1:** The facility design allowed poor quality air from the ISO 8 anteroom (differential pressure +0.029") to flow into the higher-classified ISO 7 cleanroom (differential pressure +0.026"). The firm failed to document, investigate, and correct this issue, despite aseptically compounding sterile products on the same day (8/14/2017).
*   **Observation 2:** Personnel engaged in aseptic processing had exposed hair, with a pharmacy technician's hair observed sticking out from under a hairnet on 7/26/2018. The technician's entire head extended into the ISO 5 area multiple times while compounding sterile Tri-Mix Injection lots.
*   **Observation 3:** Personnel failed to disinfect gloves to prevent contamination. On 7/26/2018, 7/31/2018, and 8/1/2018, a pharmacy technician left the ISO 5 area to

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Company: https://www.keypedia.com/companies/vita-pharmacy-llc-dba-talon-compounding-pharmacy/28ed33d2-a435-401b-9ca8-c451dca6b016

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c