# FDA 483 - Wells Pharma of Houston LLC - March 28, 2025

Source: https://www.keypedia.com/records/483/wells-pharma-of-houston-llc/e80f9e0c-e5b1-4861-bb6f-7ef274778102

> FDA 483 for Wells Pharma of Houston LLC on March 28, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wells Pharma of Houston LLC
- Inspection Date: 2025-03-28
- Product Type: Drugs
- Summary: An FDA inspection of Wells Pharma of Houston LLC, an outsourcing facility located at 9265 Kirby Dr, Houston, TX, was conducted from March 17-28, 2025. The inspection, led by Investigator Jazmine N Brown, identified nine observations regarding the firm's sterile drug product manufacturing and quality systems.

**Key Violations and Observations:**

1.  **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products were not established, written, or followed.
    *   Aseptic pharmacy technicians were observed blocking first-pass air in ISO 5 Laminar Air Flow Hoods (LAFHs) during drug product preparation (Fentanyl, Midazolam, Ketamine).
    *   Operator media fills were deficient, not fully qualifying sterile operators for all container closure units, fill volumes, or batch sizes.
    *   Media fill programs did not include all equipment used in sterile drug preparation (e.g., Ropivacaine pumps, Cefazolin preparation unit).
    *   Aseptic process validation media fills failed to represent worst-case scenarios (batch size, volume, time, interventions) and did not simulate actual single-operator production.
    *   Smoke studies were deficient in visualizing unidirectional airflow during dynamic movements in LAFHs.
    *   Operators used sterile goggles with holes, allowing potential particulate egress, and were observed leaning into ISO 5 LA

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## Related Officers

- [Jazmine N. Brown](https://www.keypedia.com/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)

Company: https://www.keypedia.com/companies/wells-pharma-of-houston-llc/35e803e2-78a7-4b40-b467-4c1ff012447d