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# Texas Longhorn RX Producing Illegal Drugs: FDA
- URL: https://www.fdaweb.com/texas-longhorn-rx-producing-illegal-drugs-fda/
- Published: 2022-09-13T12:00:00.000Z
- Updated: 2026-09-14T17:59:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152716

A 10/18/21-11/2/21 FDA inspection at Texas Longhorn RX’s Vita Pharmacy, doing business as Talon Pharmacy of Boerne, Boerne, TX, found “serious deficiencies” in the company’s practices for producing drug products intended or expected to be sterile. An 8/29 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/texas-longhorn-rx-llc-639220-08292022?ref=fdaweb.com) cites these specific instances of adulterated drugs:

- the facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area;
- the company handled hazardous drug products without providing adequate containment and segregation to prevent cross-contamination in that hazardous drug products are produced in an ISO5-classified biological safety cabinet, which is located in the same ISO7-classified cleanroom where non-hazardous drug products are produced;
- the ISO-classified areas had visibly dirty equipment and difficult-to-clean surfaces;
- the firm did not disinfect materials during the transfer from the ISO7-classified cleanroom into the ISO5-classified area;
- the firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO5 area;
- media fills were not performed under the most challenging or stressful conditions.

“It is a prohibited act … to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated,” the letter says.

FDA says one of the company’s responses to the observations on the form FDA-483 was adequate but the others were deficient. It strongly recommends that the company’s management undertake a comprehensive assessment of operations, including facility designs, procedures, personnel, processes, maintenance, materials, and systems. In particular, the letter says, the review should assess the company’s aseptic processing operations. “A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation,” the agency says.

Texas Longhorn RX was told to respond with a list of specific steps it has taken to address the violations, with any related documentation and a schedule for completing the corrections.