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

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