FDA warns Houston compounder Empower Pharma over sterility and labeling problems
A federal warning letter cites sterility and labeling problems at a Texas compounder that Lilly is suing over compounded tirzepatide, a drug the letter itself does not mention.
The FDA has issued a warning letter to Empower Pharma, a Houston-based compounding pharmacy that Eli Lilly has sued over compounded tirzepatide, citing production and labeling problems at its facility [1]. The letter was delivered in early April after an August inspection of the Houston plant and was posted to the agency's website on April 22 [1].
What the FDA found
Empower operates as a 503B outsourcing facility. That category lets compounders make bulk batches of drugs without going through the FDA's standard approval process, but they must still meet manufacturing standards and other requirements [1].
The FDA said Empower's drug products lacked key labeling information, including directions for use such as dosage and administration, and instructions for how to report side effects [1]. Inspectors also said drugs that should have been sterile were prepared, packed or held in "unsanitary conditions" that could have led to contamination [1].
The letter lists other shortfalls: failing to assess and respond properly to a microbial contamination event; not performing satisfactory smoke studies to demonstrate proper airflow in manufacturing spaces; not following up thoroughly when production results were out of specification; and lacking protocols for equipment maintenance, a consistent manufacturing process and environmental monitoring in aseptic areas [1].
The FDA said Empower released a batch of its drug pyridoxine HCL, which was recalled in September, after positive microbial growth was detected in the area where it was produced, and that the company did not provide an adequate product impact assessment [1]. Repeated lapses "demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," the agency wrote [1]. The FDA said it was "unable to fully evaluate" Empower's proposed corrective actions because the company did not supply enough documentation, and it called some corrective steps taken in the previous year "deficient" [1].
This is not the first finding against the company. Empower initially received a Form 483, a less severe inspection result, after the August inspection, and began a recall of certain products made at the Houston facility; the FDA also cited it over similar infractions in May 2024 [1].
Because of the scope of the problems, the FDA recommended a comprehensive assessment of Empower's operations, including facility design, procedures, personnel, processes and maintenance, and urged the company to bring in third-party sterile manufacturing expertise [1].
The Lilly lawsuit and the tirzepatide deadline
Empower is one of several compounders in litigation with Eli Lilly over compounded GLP-1 drugs [1]. Compounded tirzepatide was not among the Empower products flagged in the warning letter [1].
The FDA has determined that the shortage of Lilly's tirzepatide products — sold as Mounjaro for diabetes and Zepbound for weight loss — has ended, which set a March 19 deadline for many 503B outsourcing facilities to stop compounding tirzepatide [1]. Lilly's lawsuit accuses Empower of flouting that deadline and of falsely advertising its compounded tirzepatide as a personalized version of Lilly's patented drug [1]. Empower told CNBC at the time that it cautioned against cutting off access to personalized alternatives and said it was "committed to offering these life-changing formulations" [1].
Why it matters for patients
A warning letter is an enforcement document. It is not a recall or a court order, and the FDA has not said in this letter that patients should stop using anything. The findings, though, concern basics that patients and caregivers rely on: labels with dosing directions and instructions for reporting a side effect, and sterility conditions for injectable drugs [1]. Those are the areas the FDA flagged at this facility.
The timing also matters for people who have been receiving compounded tirzepatide. Federal regulators have said the branded tirzepatide shortage is over and set March 19 as the cutoff for many 503B facilities to stop compounding the drug [1]. That means compounded tirzepatide is meant to be harder to obtain, while Lilly pursues compounders in court [1].
Several things have not been disclosed: how many patients received products made at the Empower facility, whether the warning letter will lead to further regulatory action, and what Empower's formal response is. Because the letter does not address compounded tirzepatide directly, it does not settle the questions raised in Lilly's lawsuit [1].
What happens next
The FDA posted the warning letter on April 22 [1]. The agency has not reported what further steps, if any, it plans for Empower. Lilly's lawsuit against the company and the March 19 deadline for many 503B facilities to stop compounding tirzepatide remain in place [1].
Sources
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