FDA warns Empower Pharmacy over sterile production conditions at two Houston sites

The FDA issued two warning letters dated April 2, 2025 to Empower Clinic Services, LLC, doing business as Empower Pharmacy and Empower Pharma, saying sterile drug products made at its Houston facilities were prepared under insanitary conditions that could have contaminated them ^[1][2].

The first letter, WL # 700964, covers the company's 503A pharmacy at 7601 N Sam Houston Pkwy W in Houston. FDA investigators inspected that site from September 24 to October 4, 2024, and issued a Form FDA 483 on the final day ^[1]. The agency said the cleanroom certification did not include air sampling inside the critical area where aseptic processing happens, that media fills — the test runs used to show a facility can fill vials without contamination — were not performed under the most challenging conditions, and that equipment touching stoppers was not properly sterilized. The stopper sorting bowl, supply hopper and insertion station were named ^[1].

FDA reviewed the company's responses dated October 28, 2024 and January 31, 2025 and said some corrective actions looked adequate but others lacked enough supporting documentation. The agency said the April 2024 and October 2024 particle sampling for the ISO 5 filling room did not conform to ISO 14644-1:2015 because sampling locations were not divided across the whole cleanroom and were not of equal area ^[1]. It also said it remained concerned about continued injectable production "while lacking assurance that equipment, which comes into contact with product contact components, is sterile" ^[1].

The second letter, WL # 700962, covers Empower Pharma, the company's 503B outsourcing facility at 5980 West Sam Houston Parkway North, inspected from August 1 to August 28, 2024 ^[2]. FDA said a batch of drug product intended to be sterile was released even though microbial growth had been found during environmental monitoring inside the ISO 5 production area, and that the company did not provide an adequate assessment of the impact on products ^[2].

The letter cites a recovery of 1 colony-forming unit of Bacillus altitudinis/pumilus/safensis on a surface contact plate inside the ISO 5 laminar airflow hood during aseptic filling. The company identified the likely root cause as human error and a contributing factor as method, due to sampling error, but FDA said the investigation did not document preventive actions on aseptic technique and sampling ^[2]. Investigators also observed 6-inch horizontal gaps below the back wall of the ISO 5 laminar airflow hood and said a smoke study from June 26, 2023 was not conducted under dynamic conditions ^[2].

The company recalled Pyridoxine HCL Injection Solution, 100 mg/mL, lot 609763, on September 5, 2024 due to lack of sterility assurance; FDA said the lot was compounded on April 18, 2024 ^[2]. The letter also describes a batch of Ascorbic Acid Preserved 500 mg/mL Injection, 30 mL, filled on June 17, 2024, that exceeded the company's internal action level for non-viable particles and was released in full ^[2]. The posted text of that letter ends mid-sentence in the middle of that item, so FDA's full conclusion on the ascorbic acid lot is not shown ^[2].

Neither letter names a GLP-1 medication. The products identified by name are pyridoxine HCl injection and ascorbic acid injection ^[2]. Whether any compounded semaglutide or tirzepatide products were made in the affected areas or during the affected periods has not been reported.

Why it matters for patients

Compounded drugs are not FDA-approved, and these letters describe problems specific to injectables: once a drug is sealed in its vial or syringe, contamination present at filling cannot be removed by later sterilization ^[1][2]. The letters state that the cited deficiencies put patients at risk ^[1][2].

Both letters are public and identify the specific practices FDA questioned, which is one way for a patient receiving a compounded injectable to see what a supplier has been cited for. Neither letter states that any illness or injury has been linked to these products, and no recall beyond the pyridoxine lot is described ^[2].

What happens next

The 503A letter asks the company to reply in writing within 15 working days of receipt, describing steps taken to fix the violations and prevent recurrence ^[1]. The date the company received the letters has not been disclosed. FDA said failure to adequately address violations may lead to legal action, including seizure and injunction ^[1].

FDA also recommends that management conduct a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials and systems, with help from a third-party consultant who has sterile drug manufacturing expertise ^[1].