# FDA 483 - Constant Irwindale, Inc. - November 15, 2024

Source: https://www.keypedia.com/records/483/constant-irwindale-inc/d8a3a6ec-19c6-43fc-8baf-b7bc449e390f

> FDA 483 for Constant Irwindale, Inc. on November 15, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Constant Irwindale, Inc.
- Inspection Date: 2024-11-15
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: During an inspection from November 6-15, 2024, at Constant Irwindale, Inc., a sterile animal drug manufacturer located at 5539 Ayon Ave, Irwindale, CA, the FDA observed several deficiencies. Ricardo V Morales, Production Manager, was issued the Form 483.

**Key Observations:**

1.  **Lack of Procedures for Preventing Microbiological Contamination:**
    *   Media fills do not accurately challenge routine production operations, failing to document inherent intervention frequency, total duration of corrective interventions, and breakdown activities.
    *   Trending of media fill data, as per procedure PR-OP-042, was not performed.
    *   A media fill was not conducted before decommissioning an aseptic filling line on July 19, 2023, despite numerous batches of sterile Penicillin G Procaine Suspension being filled afterward.
    *   Operators with expired gown qualifications worked in the aseptic filling area.
    *   100% visual inspection is not performed against black and white backgrounds.

2.  **Deficient Environmental Monitoring in Aseptic Processing Areas:**
    *   HEPA filters were not re-certified before decommissioning in the filling room, affecting batches of sterile drug product.

3.  **Deficient Cleaning and Disinfection Procedures:**
    *   Disinfectant efficacy studies were not performed on all materials used, specifically (b)(4

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Company: https://www.keypedia.com/companies/constant-irwindale-inc/ae8e2506-2f78-40c9-ace9-2a00607c076a

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b