# FDA 483 - infusion systems of sw florida inc.  - December 22, 2014

Source: https://www.keypedia.com/records/483/infusion-systems-of-sw-florida-inc/022f4c0f-933a-4eb7-a75c-6b37eb6ebc6d

> FDA 483 for infusion systems of sw florida inc.  on December 22, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: infusion systems of sw florida inc. 
- Inspection Date: 2014-12-22
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483 document details observations made during an inspection related to the manufacturing of sterile drug products.

**Facility and Operation Details:** The inspection focused on the preparation of sterile drug products, specifically within a laminar flow hood (ISO 5) and a Buffer room.

**Violations and Observations:**
*   **Sterilization Process Validation:** Procedures for preventing microbiological contamination of sterile drug products lack validation of the sterilization process.
*   **Aseptic Deficiencies:**
    *   Personnel did not sanitize items (e.g., bags containing vials, syringes, and REDACTED) before placing them into the laminar flow hood.
    *   Personnel rested forearms inside the laminar flow hood during sterile drug preparation.
    *   Personnel entered the Buffer room with non-sterile gloves, removed them inside the laminar flow hood, and exposed bare hands while donning sterile gloves.
    *   Personnel did not periodically sanitize gloves with REDACTED during sterile drug preparation.
    *   Bare skin (forearms) was exposed under the laminar flow hood due to ill-fitting gowns.
*   **Environmental Monitoring:** Aseptic processing areas have deficient systems for monitoring environmental conditions.
*   **Cleaning and Disinfection:** Aseptic processing areas have deficient systems for cleaning and disinfecting rooms and equipment to achieve aseptic conditions.
*   **Protective Apparel:** Protective apparel is not worn as necessary to protect drug products from contamination.
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## Related Officers

- [Approval Manager](https://www.keypedia.com/people/michael-h-tollon/5e30e7e1-5727-4169-8faf-e5d5783ac781)

Company: https://www.keypedia.com/companies/infusion-systems-of-sw-florida-inc/11bb6987-e578-45f3-b4ba-6be67cec9cae

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9