FDA cites Houston RX for 14 sterility problems behind tirzepatide recall
Inspectors found exposed skin in the ISO 5 hood, negative cleanroom pressure and research-grade semaglutide, tirzepatide and sermorelin ingredients.
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By Daniel Okafor · Regulatory Correspondent
Oct 19 07:00 ETSource: Medical Daily
The wire
- 01A Form 483 from an August 20-28 inspection lists 14 observations at Houston RX LLC, which later recalled 64 vials of compounded tirzepatide with niacinamide for lack of sterility assurance.
- 02Observations include microbial growth recovered in the ISO 5 hood after a tirzepatide-niacinamide fill with no investigation, hand-stoppering, unsterilized beakers and apparent mold on a vent near the cleanroom.
- 03A Form 483 is not a final compliance determination and the firm may respond; Medical Daily could not locate a public response from Houston RX.
From the source
Read at medicaldaily.comHouston Pharmacy Behind Recalled Compounded Tirzepatide Vials Drew 14 FDA Inspection Observations, Including Exposed Skin and Research-Grade Ingredients
Federal inspectors who spent six days inside a Houston compounding pharmacy in August documented 14 problems with how it made sterile injectable drugs, including compounded GLP-1 weight-loss shots , according to an FDA inspection report . The pharmacy, Houston RX LLC, later recalled 64 vials of compounded tirzepatide with niacinamide because of a lack of assurance of sterility.
