# FDA 483 - I.V. Specialty, Ltd - July 28, 2017

Source: https://www.keypedia.com/records/483/iv-specialty-ltd/1af4bb69-9253-4e1d-b5e4-83c74c89b8b9

> FDA 483 for I.V. Specialty, Ltd on July 28, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: I.V. Specialty, Ltd
- Inspection Date: 2017-07-28
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 documents observations from an inspection, highlighting deficiencies in facility maintenance, aseptic practices, and cleaning/sanitizing procedures for sterile drug processing.

**Facility and Operations:** The facility processes sterile drugs within an ISO 7 clean room and an ISO 5 laminar air flow (LAF) hood. An ante room is intended to meet ISO 8 standards.

**Violations and Observations:**
*   **Vermin:** Vermin was observed adjacent to the production area. A dead spider was found in a HEPA filter in the ISO 7 clean room, near the ISO 5 LAF hood.
*   **Clean Room Surfaces and Equipment:**
    *   ISO-classified areas contained difficult-to-clean, particle-generating, or visibly dirty equipment/surfaces.
    *   LAF Hood (b)(4) had loose panels above the aseptic processing area.
    *   LAF Hood (b)(4) had a loose access panel below the processing table.
    *   Dirt, debris, stains, and a 2-inch hair were observed in the front recirculation vent of the ISO 5 hood.
    *   LAF Hood (b)(4) was on a multi-surface (wood fiber board, stainless steel, painted, formica) table, making it difficult to sanitize.
    *   An office-style telephone with wiring on the floor created a difficult-to-sanitize

## Related Documents

- [WARNING_LETTER - 2014-07-22](https://www.keypedia.com/records/warning_letter/iv-specialty-ltd/e5f18d22-5f3a-43d7-ac86-78a8753574c0)
- [483 - 2016-02-05](https://www.keypedia.com/records/483/iv-specialty-ltd/459e06c7-eb2f-4d08-beff-2a0d43ec7890)
- [483 - 2014-07-17](https://www.keypedia.com/records/483/iv-specialty-ltd/7f29c19f-b3bb-4b5c-83e5-88e857799ce9)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Regulatory Project Manager](https://www.keypedia.com/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)

Company: https://www.keypedia.com/companies/iv-specialty-ltd/6d5e813d-b8c0-44bc-b6a0-5312a9f695c2

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