# FDA 483 - IV Solutions of Lubbock - March 20, 2013

Source: https://www.keypedia.com/records/483/iv-solutions-of-lubbock/b3657cd6-2e26-4e9f-be77-e87009d44a62

> FDA 483 for IV Solutions of Lubbock on March 20, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IV Solutions of Lubbock
- Inspection Date: 2013-03-20
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details multiple deficiencies observed during an inspection of a drug product manufacturing facility.

**Facility and Operations:** The facility processes drug products, including Vancomycin, Ceftriaxone, and Tobramycin Ampules for Inhalation, in an ISO 7 clean room with ISO 5 hoods.

**Violations and Observations:**

*   **Personnel Gowning:** Personnel engaged in aseptic processing wore non-sterile hair covers, mouth covers, and gowns. On March 18 and 19, 2013, a technician in the ISO 5 Hood had exposed face, neck, and hair. Gowning worn outside the clean room did not completely cover clothing around the neck, below the knee, and backside.
*   **Building Construction:** The ISO 7 Clean Room's exhaust air vent is above the ISO 5 workbench level, potentially causing turbulent airflow.
*   **Airflow Verification:** No smoke studies were conducted to verify laminar airflow in ISO 5 Hoods.
*   **HEPA Filter Testing:** HEPA filters in the ISO 7 clean room and ISO 8 ante-room are not regularly leak tested; only visual checks and total airflow measurements are performed. No written procedure exists for HEPA filter certifications or frequency.
*   **Equipment Design:** An ISO 5 hood workbench has exposed wood laminate material around its edges, which is harder to disinfect than stainless steel.
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## Related Documents

- [483 - 2007-06-08](https://www.keypedia.com/records/483/iv-solutions-of-lubbock/c8ee71c9-54ba-4cf5-9b32-17634a284d29)
- [WARNING_LETTER_RESPONSE - 2013-03-28](https://www.keypedia.com/records/warning_letter_response/iv-solutions-of-lubbock/49585938-f656-43a6-bcc8-94cba4af0e5c)
- [OTHER_CORRESPONDENCE - 2013-03-19](https://www.keypedia.com/records/other_correspondence/iv-solutions-of-lubbock/d80573ef-ab3c-41a3-b4e9-932e0b354314)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [GDUFA Supervisory Investigator](https://www.keypedia.com/people/paul-c-mouris/0da88ac4-d475-412f-8505-5a43dc8aea41)

Company: https://www.keypedia.com/companies/iv-solutions-of-lubbock/892d6a60-d120-498a-bc3f-d9b90738be37

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