# FDA 483 - Mixlab TX LLC - February 03, 2012

Source: https://www.keypedia.com/records/483/mixlab-tx-llc/52ae5872-a253-45ab-8216-6ee792b8807f

> FDA 483 for Mixlab TX LLC on February 03, 2012. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mixlab TX LLC
- Inspection Date: 2012-02-03
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: On February 3, 2012, the FDA issued a Form 483 to Weatherford Compounding Pharmacy LLC, a veterinary compounding pharmacy located at 175 College Park Drive #175, Weatherford, TX 76086. The inspection, conducted on 10/3-5/11, 10/13/11, and 2/3/12, identified five observations.

Observation #1 noted a lack of documentation for media fills to validate the sterilization process for compounded sterile preparations (CSPs) for parenteral use, citing examples like Enrofloxacin/Flunixin/Vitamin B12 (lot #EFB0911), Ceftiofur/Enrofloxacin/Vitamin B12 (lot #CFE110110), and Tulathromycin/Ceftiofur/Flunixin (lot #TCF111810).

Observation #2 indicated a failure to provide data demonstrating depyrogenation of glass vials and closures used in CSP compounding.

Observation #3 stated that documentation was not provided to show that the firm conducted (b)(4) after CSP compounding.

Observation #4 highlighted a failure to investigate potency failures for CSPs, specifically Ceftiofur/Flunixin/Vitamin B-12 (lot #CEF091010) with potency results of 73.

## Related Documents

- [483 - 2017-06-14](https://www.keypedia.com/records/483/mixlab-tx-llc/bc3f6416-0f55-4e1a-98f3-cd365088a40e)
- [483 - 2024-08-02](https://www.keypedia.com/records/483/mixlab-tx-llc/80ef59e4-b9fe-4791-9df6-5a0166937a11)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)
- [Anh M. Lac](https://www.keypedia.com/people/anh-m-lac/20a897c2-ad8c-4bea-8060-34ba80d64d1e)
- [Program Manager](https://www.keypedia.com/people/anli-lac/4a7229d0-cd17-41e4-97d4-ed5847aa59f0)

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9