FDA sends a warning letter to a Texas outsourcing facility named in Lilly's suit

The Food and Drug Administration issued a warning letter to Empower Pharma, a Houston-based 503B outsourcing facility, citing a long list of manufacturing violations found during an inspection last August ^[1]. The letter, posted to the FDA's website on April 22, 2025, came about two weeks after Eli Lilly filed a lawsuit accusing the company of continuing to sell compounded tirzepatide after a federal deadline to stop ^[1].

The FDA's letter does not mention compounded tirzepatide by name. Instead, it lays out broader problems with how Empower runs its facility ^[1]. Inspectors found that drug labels lacked basic information, including how to report side effects and instructions for dosage and use, which the agency said violated the rules that let 503B outsourcers make bulk drug batches without full FDA approval ^[1]. Inspectors also said sterile products were prepared, packed, or held in "unsanitary conditions" that could lead to contamination ^[1].

The letter details specific failures: Empower did not properly investigate a microbial contamination event, skipped adequate smoke studies to check airflow in production areas, and lacked consistent protocols for equipment maintenance and environmental monitoring ^[1]. The FDA also flagged a batch of the drug pyridoxine HCL that was recalled in September after Empower released it despite finding positive microbial growth in the production area ^[1]. The agency said it could not fully evaluate Empower's proposed fixes because the company did not turn over enough documentation ^[1].

This is not Empower's first brush with FDA scrutiny. The company received a less severe Form 483 last summer after the same inspection and started a recall of some products, but the agency said in May 2024 it had cited Empower for similar problems before ^[1]. In the new letter, the FDA said Empower's corrective steps over the past year were "deficient" and called for a full review of its facility design, staffing, processes, and maintenance, including outside help with sterile manufacturing ^[1].

Why it matters for patients

Empower is one of many compounding pharmacies that stepped in to make copies of tirzepatide, the drug in Lilly's Mounjaro and Zepbound, while the brand-name products were in short supply ^[1]. The FDA determined that shortage had ended, setting a March 19, 2025 deadline for many 503B outsourcers to stop compounding tirzepatide ^[1]. Lilly's lawsuit claims Empower kept selling compounded tirzepatide after that date, marketing it as a personalized version of the patented drug ^[1].

For patients who have been getting compounded tirzepatide from Empower or similar facilities, this warning letter adds a separate layer of concern beyond the legal dispute over the compounding deadline. The FDA's findings about sterility gaps and unclear labeling raise questions about the quality control at this specific facility, independent of whether the products it made were legal to sell ^[1]. Patients relying on compounded versions of GLP-1 drugs may want to be aware that oversight of these facilities is uneven, and that a Form 483 citation from a year earlier did not stop the same problems from recurring ^[1].

Empower has defended its practice, telling CNBC it remains "committed to offering these life-changing formulations" and warning against cutting off access to personalized alternatives ^[1].

What happens next

The FDA has asked Empower to conduct a comprehensive review of its manufacturing operations and to bring in outside expertise on sterile production ^[1]. It is not yet known from available sources whether Empower has responded to the warning letter or what steps, if any, it has taken since April 22 ^[1]. Lilly's lawsuit against Empower over compounded tirzepatide sales after the March 19 deadline remains pending, and the sources do not indicate a resolution date ^[1].