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What this platform discloses publicly, plus the free public registries you can use to check a prescriber license, board certification, and disciplinary history yourself. LoseLab does not perform these checks for you.
A regulator or court has taken a documented action involving this company. Every one is linked to its primary source below — open it and judge for yourself.
No clinical lead named publicly on the platform’s site.
Regulatory & legal record
Warning letter after a September-October 2024 inspection of the Houston facility. FDA found microbial contamination recovered inside the ISO 5 aseptic processing area without an adequate investigation, and smoke studies too weak to show the airflow protecting sterile product. In plain terms: injectables meant to be sterile were made in an environment the FDA said may not protect against contamination. FDA also flagged the aseptic-monitoring failure as a repeat of an issue raised with the firm at a May 2023 regulatory meeting.
Read the source: FDA Warning Letter #700964 (Apr 2, 2025)An earlier warning letter to the same firm. It matters because it shows the 2025 findings were not a first offense — the pattern is what turns a citation into a reason to walk away.
Read the source: FDA Warning Letter #613792 (Oct 15, 2021)What the platform discloses publicly
What you still can’t check
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