# FDA 483 - LEESAR, INC - July 12, 2017

Source: https://www.keypedia.com/records/483/leesar-inc/cbc8d837-acb3-4912-86b0-2b949c14a912

> FDA 483 for LEESAR, INC on July 12, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LEESAR, INC
- Inspection Date: 2017-07-12
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: This FDA Form 483 details deficiencies observed during an inspection of a facility involved in aseptic processing and drug compounding.

**Facility and Operations:** The firm operates aseptic processing areas, including ISO 5, ISO 7, and ISO 8 rooms, and utilizes automated compounding systems (regulated as Class II medical devices).

**Violations and Observations:**

*   **Aseptic Processing Deficiencies:**
    *   Use of non-sterile cleaning agents for routine cleaning in ISO 5, ISO 7, and ISO 8 areas.
    *   Pharmacy technicians handling drug components outside the ISO 5 area without sanitizing gloved hands multiple times while loading/unloading compounding systems.
    *   Deficiencies in maintaining aseptic conditions, including:
        *   Airflow studies under dynamic conditions not following vendor protocols.
        *   Airflow studies failing to determine if processing equipment impedes unidirectional airflow in ISO 5 areas.
        *   Room certifications for 2015 and 2016 not accounting for increased personnel in the ISO 7 area. (Repeat Observation)
*   **Investigation Failures:**
    *   Failure to investigate 3,855 rejections in 2016 and 2,278 rejections in 2017 from compounding systems, primarily due to weight errors or invalid dosing volume (59.30% in 2016,

## Related Documents

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## Related Officers

- [June P. Page](https://www.keypedia.com/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)
- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Division Director](https://www.keypedia.com/people/ian-f-deveau/81581024-352f-40f2-9060-92ac321b87ad)
- [Justine C. Tomasso](https://www.keypedia.com/people/justine-c-tomasso/8a0f6e96-ae0f-47d3-a992-cff9f676e807)

Company: https://www.keypedia.com/companies/leesar-inc/275b969d-7cd2-4c17-af66-d7ed6ff4dec1

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea