# FDA 483 - Mixlab TX LLC - August 02, 2024

Source: https://www.keypedia.com/records/483/mixlab-tx-llc/80ef59e4-b9fe-4791-9df6-5a0166937a11

> FDA 483 for Mixlab TX LLC on August 02, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mixlab TX LLC
- Inspection Date: 2024-08-02
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: From July 23, 2024, to August 2, 2024, the FDA inspected Mixlab TX LLC, a producer of sterile and non-sterile drug products in Weatherford, TX. The inspection, led by Margaret M Annes and Stephanie M Mongeluzzi, identified eight observations regarding the firm's quality control, manufacturing, and testing procedures.

Key observations include:
1.  **Quality Control Unit Deficiencies:** The firm lacks written procedures for the Quality Unit's responsibilities, including drug product release/rejection. Sterile drug products are released before final sterility test results are received, and there's no documented review/approval by the quality control unit.
2.  **Sterilization and Aseptic Process Validation:** Sterilization cycles for injectable drug products are not validated. Media fills do not simulate actual production conditions or cover worst-case scenarios, and documentation for media fills is incomplete.
3.  **Environmental Monitoring Deficiencies:** Environmental and personnel monitoring in classified areas (ISO 5/ISO 7) is not performed daily during sterile drug production. Monitoring is not conducted during media fills.
4.  **Container/Closure Processing Validation:** Cleaning, sterilization, and depyrogenation processes for stoppers, vials, and filling equipment are not validated. There's no system to track re-sterilized components.
5.  **Sterility and Endotoxin Testing:** Diclazur

## Related Documents

- [483 - 2012-02-03](https://www.keypedia.com/records/483/mixlab-tx-llc/52ae5872-a253-45ab-8216-6ee792b8807f)
- [483 - 2017-06-14](https://www.keypedia.com/records/483/mixlab-tx-llc/bc3f6416-0f55-4e1a-98f3-cd365088a40e)

## Related Officers

- [Stephanie M. Mongeluzzi](https://www.keypedia.com/people/stephanie-m-mongeluzzi/021dce73-8444-4936-a7da-254e67705021)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/mixlab-tx-llc/7f0fa4f0-f78b-4ea6-b854-9a102bf6f237

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c