FDA issues two warning letters to Empower Pharmacy

The FDA issued two warning letters dated April 2, 2025 to Empower Clinic Services, LLC, the Houston company that operates both a compounding pharmacy and a registered outsourcing facility. Both letters describe "serious deficiencies" in how the company made drugs intended to be sterile, and both say the agency could not fully accept the company's proposed fixes. ^[1][2]

What the letters say

The first letter, WL #700964, went to the quality director at Empower Pharmacy's site at 7601 N Sam Houston Pkwy W. FDA investigators inspected that facility from September 24 to October 4, 2024, and issued a Form FDA 483 on October 4. The company responded on October 28, 2024 and January 31, 2025. ^[1]

Inspectors found that routine environmental monitoring did not include sampling inside the critical area where aseptic processing actually happens; that media fills — test runs using growth media instead of drug to prove a line can fill sterile product — were not done under the most challenging conditions; and that the stopper sorting bowl, supply hopper and insertion station used to make injectable drugs were not sterilized. FDA said these conditions made the drugs adulterated under section 501(a)(2)(A) of the federal drug law. ^[1]

FDA also pushed back on Empower's proposed corrections. The agency said particulate sampling during the April 2024 and October 2024 cleanroom certifications did not appear to follow the ISO 14644-1:2015 standard the company cited, and warned that "any microbial contamination in the ISO 5 area is a serious concern and considered an insanitary condition." It said it "remain[s] concerned with your continued injectable drug production" while the company lacks assurance that product-contact equipment is sterile. ^[1]

The second letter, WL #700962, went to the CEO of Empower Pharma's outsourcing facility at 5980 West Sam Houston Parkway North, which first registered as a 503B outsourcing facility on July 16, 2016 and most recently on December 6, 2024. That site was inspected August 1–28, 2024, with a Form 483 issued August 28. ^[2]

There, FDA cited five separate current good manufacturing practice violations, including failure to follow written procedures designed to prevent microbial contamination, failure to thoroughly investigate batch discrepancies, and inadequate environmental monitoring of aseptic areas. The letter notes that Empower recalled Pyridoxine HCl Injection Solution, 100 mg/mL, lot 609763 on September 5, 2024 for lack of sterility assurance — a batch released even though 1 CFU of Bacillus altitudinis/pumilus/safensis was recovered on a surface plate inside the ISO 5 laminar airflow hood during aseptic filling. Investigators also observed 6-inch horizontal gaps below the back wall of an ISO 5 hood, and said a smoke study dated June 26, 2023 was not run under dynamic conditions to show airflow was unidirectional. A lot of Ascorbic Acid Preserved 500 mg/mL Injection filled June 17, 2024 exceeded the firm's own non-viable particle action level and was still released. ^[2]

FDA also said the outsourcing facility's Pyridoxine HCl labels lacked MedWatch adverse-event reporting information and directions for use, which means those products do not qualify for the 503B exemptions from FDA approval and labeling rules. ^[2]

Why it matters for patients

Neither letter names semaglutide, tirzepatide or any GLP-1 product; the specific drugs discussed are pyridoxine and ascorbic acid injections. ^[1][2] But the findings are about the sterile filling lines and cleanrooms themselves, not about one ingredient. FDA's core complaint is that the company could not consistently demonstrate that injectable products leaving these rooms were sterile — a concern that would apply to anything filled there.

Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before they are sold. A warning letter is not a recall and does not by itself stop shipments. The only recall mentioned is the single pyridoxine lot from September 2024. ^[2] Whether any other products were affected is not stated in these letters, and FDA notes the violations "are not intended to be an all-inclusive statement of violations." ^[1]

What happens next

FDA gave the company 15 working days from receipt to describe in writing the specific steps taken, with supporting documentation. The agency said failure to adequately address the violations "may result in legal action without further notice, including, without limitation, seizure and injunction," and recommended a comprehensive third-party assessment of aseptic operations. ^[1][2] Empower's response and any follow-up FDA action are not included in these documents.