# FDA 483 - Infusion Options, Inc. - June 25, 2019

Source: https://www.keypedia.com/records/483/infusion-options-inc/7ca6bd77-56ca-42f0-982d-cb100f05bd84

> FDA 483 for Infusion Options, Inc. on June 25, 2019. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infusion Options, Inc.
- Inspection Date: 2019-06-25
- Office Name: New York District Office
- Summary: This FDA Form 483 details observations from an inspection of Infusion Options, Inc., an outsourcing facility located at 5924 13th Ave, Brooklyn, NY, conducted from May 6 to June 25, 2019. Estee Altman is the CEO.

The inspection revealed 17 observations related to drug product storage, aseptic processing, facility control, quality systems, and regulatory compliance.

Key violations include:
- **Improper Storage:** Drug products requiring refrigeration were stored in an actively used warehouse bathroom, compromising identity, strength, quality, and purity. Lack of document control for these products was noted.
- **Aseptic Technique Deficiencies:** Numerous failures in aseptic processing were observed, including operators disrupting ISO-5 HEPA airflow, inadequate disinfection contact time, improper material transfer techniques (e.g., throwing bags into LAF, bare-arm transfers), and poor gowning practices (e.g., ungowned personnel in clean areas, touching floor with gowns, inadequate goggle use).
- **Unauthorized Access:** Untrained personnel, including a driver, accessed aseptic areas ungowned and handled compounding materials.
- **Procedure Non-Adherence:** Expired Dextrose 5% IV bags were used for drug preparation.
- **Environmental Monitoring Deficiencies:** Lack of continuous non-viable particulate testing in ISO 5 areas and issues with HEPA filters were noted.
- **Facility Maintenance:**

## Related Documents

- [483 - 2014-04-23](https://www.keypedia.com/records/483/infusion-options-inc/aa8aba41-c866-4be1-95ec-e93066a49bde)
- [483 - 2017-06-01](https://www.keypedia.com/records/483/infusion-options-inc/72171d51-5f98-4b57-acc5-0efd3c2b0de7)
- [WARNING_LETTER - 2019-06-25](https://www.keypedia.com/records/warning_letter/infusion-options-inc/da11f2cd-585f-4c4e-a015-acb4f8e648bd)

## Related Officers

- [Kevin J. Flessa](https://www.keypedia.com/people/kevin-j-flessa/68fcd7c3-63df-4744-a56c-335e47e255ff)
- [Jose R. Hernandez](https://www.keypedia.com/people/jose-r-hernandez/7a28c3ee-b023-44cc-b179-b89798e2f72f)

Company: https://www.keypedia.com/companies/infusion-options-inc/bd1c7ac1-3753-4fce-96cf-d867fc626766

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d