# FDA 483 - LEESAR, INC - August 08, 2014

Source: https://www.keypedia.com/records/483/leesar-inc/436b0bcd-d853-4d1b-9d99-e3af334ce39c

> FDA 483 for LEESAR, INC on August 08, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LEESAR, INC
- Inspection Date: 2014-08-08
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: This FDA Form 483 was issued to LeeSar, INC, an Outsourcing Facility located at 2727 Winkler Ave, Fort Myers, FL, following an inspection from August 4-8, 2014. The inspection identified six observations related to aseptic processing, environmental control, personnel practices, sterilization validation, cleaning, and quality control.

**Key Observations:**

1.  **Deficient Aseptic Processing Areas (Equipment Control):**
    *   The pressure differential gauge between the ISO 7 clean room and ISO 8 ante room is not monitored daily during production.
    *   Airflow studies were not performed under static or dynamic conditions to verify that processing equipment does not impede unidirectional airflow in the ISO 5 classified area.

2.  **Deficient Aseptic Processing Areas (Environmental Monitoring):**
    *   The environmental monitoring program lacks daily surface or viable air sampling in ISO 5 classified areas during production.
    *   It also lacks monitoring of non-viable particles in ISO 5 areas under dynamic conditions and personnel monitoring.

3.  **Inappropriate Personnel Clothing:**
    *   Non-sterile gowns are used during aseptic operations, including loading components and vials into the ISO 5 IV classified area.
    *   Gowns are reused throughout the day.

4.  **Lack of Sterilization Process Validation:**
    *   Procedures to prevent microbiological contamination do not include validation

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## Related Officers

- [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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9