Wells Pharma of Houston, LLC
Wells Pharma of Houston, LLC, a 503B outsourcing facility in Houston, TX, received an FDA Warning Letter following a March 2025 inspection that identified serious CGMP deficiencies and failures to meet section 503B conditions. The facility produced sterile drug products (including Fentanyl and Phenylephrine formulations) under insanitary conditions—including cracked laminar airflow hood plexiglass, inadequate smoke studies, and deficient media fills—rendering them adulterated. Drug products also lacked required 'This is a compounded drug' labeling and the facility had inadequate adverse event reporting procedures, causing products to be ineligible for 503B exemptions and thus constitute unapproved new drugs and misbranded products. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (4)
Some of your facility's drug products, such as Fentanyl 50 mcg/10 mL in 0.9% Sodium Chloride and Phenylephrine Hydrochloride 800 mcg/10 mL in 0.9% Sodium Chloride, did not include the following statement on the label: "This is a compounded drug."
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, CFR (or any successor regulations).
You do not have any FDA-approved applications on file for drug products that you compound.
Required actions (4)
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. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
in CC-HOU-2025-039, you also state that you will "[r]eview all commercial product labels and update to include the phrase 'This is a compounded drug' OR 'This is a repackaged drug' as appropriate."
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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