New Vitalis, LLC dba New Vitalis Pharmacy
FDA issued a warning letter to New Vitalis, LLC dba New Vitalis Pharmacy (Louisville, KY) following an August 2021 inspection that found serious insanitary conditions in its sterile compounding operations, including vermin near production areas, dirty surfaces, improper aseptic technique, and unsealed HEPA filters. These deficiencies caused drug products — including Testosterone Cypionate/Testosterone Propionate — to be adulterated under section 501(a)(2)(A) of the FDCA. The firm had already voluntarily recalled the affected testosterone products and ceased all sterile compounding by September 7, 2021. FDA warned that failure to adequately address violations may result in seizure and injunction, and required a written response within 15 working days.
Required actions (3)
FDA acknowledges that on September 22, 2021, your firm voluntarily recalled all Testosterone Cypionate/Testosterone Propionate 180mg/mL, 20mg/ML within expiry produced on or prior to September 7, 2021 and ceased all sterile compounding effective September 7, 2021.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs intended or expected to be sterile.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker