Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals
FDA issued a warning letter to Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals, a 503B outsourcing facility in Irving, TX, following a May–June 2024 inspection that revealed adulterated sterile drug products, CGMP violations, and labeling deficiencies. The facility's compounded products—including Testosterone Cypionate injections and Ketoconazole cream—were found to be adulterated due to insanitary conditions and inadequate aseptic processing controls, and misbranded due to missing inactive ingredient information on labels. FDA determined the products do not qualify for 503B exemptions and are being marketed as unapproved new drugs, warning that failure to correct violations may result in seizure or injunction.
Flagged claims (4)
You do not have any FDA-approved applications on file for drug products that you compound.
there is minimal, if any, interaction/contact between the pellet within the vial and the cap, and thus there is no impact against any product which has or is being processed using caps that are processed by the current (b)(4) by rinsing procedure. There is no scientific basis for the justification of your claim.
Ketoconazole 2% (b)(4) Cream, Testosterone Cypionate 200 mg/ml injections, and Testosterone Cypionate 200 mg/ml + Testosterone Propionate 10 mg/ml injections, did not include the following information on the label: The quantity or proportion of each inactive ingredient.
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
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