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  5. Empower Clinic Services, LLC dba Empower Pharmacy - 738238 - 09/18/2026
  1. Warning Letters

WARNING LETTER

Empower Clinic Services, LLC dba Empower Pharmacy MARCS-CMS 738238 —

Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Arta Shaun Noorian
Recipient Title
Founder & Chief Executive Officer
Empower Clinic Services, LLC dba Empower Pharmacy

7601 N. Sam Houston Pkwy W., Ste. 100
Houston, TX 77064-3595
United States

(b)(4)
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER 

WL # 738238

September 18, 2026

Dear Mr. Noorian:

From November 3, 2025, through November 14, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Empower Clinic Services, LLC dba Empower Pharmacy, located at 7601 N. Sam Houston Pkwy W., Ste. 100, Houston, TX 77064. During the inspection, the investigators collected evidence indicating that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 353a] for exemption from certain provisions of the FD&C Act. In addition, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.

FDA issued a Form FDA 483 to your firm on November 14, 2025. FDA acknowledges receipt of your facility’s responses, dated December 8, 2025, March 18, 2026, and April 30, 2026. Based on this inspection, it appears that you produced drug products that violate the FD&C Act.

A. Compounded Drug Products Under the FD&C Act

Section 503A of the FD&C Act describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FD&C Act: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].1 Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.

In addition, for a compounded drug product to qualify for the exemptions under section 503A, a licensed pharmacist or physician must not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product.2 Section 503A(b)(2) provides that a compounded drug product is not essentially a copy of a commercially available drug product if “there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.” (sections 503A(b)(1)(D) and 503A(b)(2) of the FD&C Act [21 U.S.C. §§ 353a(b)(1)(D) and 353a(b)(2)]).

B. Failure to Meet the Conditions of Section 503A

During the inspection, the FDA investigators collected evidence indicating that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigators collected evidence indicating that your firm compounded drug products that are essentially copies of commercially available drug products regularly and in inordinate amounts. Specifically, your firm compounded products including TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML), SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML), and TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML), which appear to be essentially copies of FDA-approved semaglutide and tirzepatide products.3, 4 FDA is aware of high demand for compounded versions of FDA-approved semaglutide and tirzepatide products. The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual.

According to your firm's records, for example, you compounded and filled orders for the aforementioned drug products in the following quantities:

  • During July 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).
  • During August 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).
  • During September 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).
  • During October 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML).
  • During July 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).
  • During August 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).
  • During September 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).
  • During October 2025, you compounded and filled more than (b)(4) orders of SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML).
  • During July 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).
  • During August 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).
  • During September 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).
  • During October 2025, you compounded and filled more than (b)(4) orders of TIRZEPATIDE/NIACINAMIDE (2.5 ML)(8/2 MG/ML).

Evidence collected includes (1) orders/prescriptions that lack any prescriber determination of significant difference from the commercially available product; (2) orders/prescriptions with purported prescriber determinations of “significant difference” that appear to be repeated verbatim across many records, suggesting that they may be pre-generated for selection by the prescriber, rather than written by the prescriber for an identified individual patient; and (3) the volume of particular products compounded and orders filled. Generating prescriptions through means that undermine the individualized nature of a prescriber's clinical judgment (for example through third-party technology platforms that provide prescribers with pre-selected menu options for choosing a statement of significant difference) call the individualized nature of those determinations into question, potentially undermining claims that such prescriber determinations of significant difference are sufficient to meet the conditions of section 503A.

Furthermore, production records collected during the inspection indicate that your firm compounded these drug products regularly or in inordinate amounts.

Therefore, you compounded drug products that do not meet the conditions of section 503A and are not eligible for the exemptions in that section, including the FDA approval requirement of section 505 of the FD&C Act, the requirement under section 502(f)(1) of the FD&C Act that labeling bear adequate directions for use, and the requirement of compliance with CGMP under section 501(a)(2)(B) of the FD&C Act. In the remainder of this letter, we refer to your drug products that do not qualify for exemptions under section 503A as the “ineligible drug products.”

Specific violations are described below.

C. Violations of the FD&C Act

Adulterated Drug Products

The FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FD&C Act. For example, the investigators observed the following:

1. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

2. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

Furthermore, the manufacture of the ineligible drug products is subject to FDA’s CGMP regulations, Title 21, Code of Federal Regulations (CFR), parts 210 and 211. The FDA investigators observed significant CGMP violations at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The violations included, for example:

1. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).

2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

4. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

5. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

Unapproved New Drug Products

You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.5 Under sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. § 331(d)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FD&C Act.

Misbranded Drug Products

The ineligible drug products you compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses.6 Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FD&C Act. It is also a prohibited act under section 301(k) of the FD&C Act to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.

D. Corrective Actions

We have reviewed your firm’s response to the Form FDA 483.

Regarding your response related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation. Specifically, your response states that the smoke study under Rev. 005 was executed March 30 – April 3, 2026, but the April 2026 study is still under post-execution review and has not been finalized or provided to FDA. Per your response, the study “remains in controlled post-execution review.” It is unclear whether your firm has completed the post-execution review, as no final formal summary report has been provided.

Regarding your response related to the insanitary conditions, the following corrective actions appear deficient. With respect to your aseptic media fill simulation executed in January 2026, we note that the summary states, “Following the 14-day incubation period, all vials were visually inspected for turbidity or microbial growth. No contamination was observed in any of the (b)(4) vials, confirming the sterility assurance of the process.” However, our review of the media fill test records and the vials documented across the (b)(4) revealed gaps and discrepancies. The summary report does not appear to match the number of vials inspected per the documents provided in the media fill test records. Specifically, based on the vials recorded across all the (b)(4) records, it appears up to (b)(4) vials were examined. No explanation was provided for the discrepancy in the total number of vials. The documents provided show no records for (b)(4). Furthermore, the records document results for (b)(4), with no documentation or explanation for (b)(4). It is unknown if these (b)(4) exist.

Additionally, upon review of the documents, multiple (b)(4) were labeled as “N/A.” It is unknown what the designation “N/A” means, as it is not defined or explained in the records. Based on the documents provided, it is unclear how your firm counted and determined that no contamination was present in a total of (b)(4) vials. There appears to be a gap in the documentation with no explanation provided. The summary report claims all vials were inspected and none showed contamination; however, based on the information provided the claim cannot be supported if records do not clearly demonstrate that all vials were accounted for and inspected.

Finally, our review also noted multiple media fill records were transcribed on Form Revision 3 because the original results were documented on the wrong form. Transcribing original data onto a different document, even if done for legitimate administrative reasons, must be carefully controlled, documented, and justified. Without a clear audit trail showing why results were rewritten and who authorized it, this practice raises concerns about whether the data accurately reflects what actually occurred during the media fill.

Please be aware that section 501(a)(2)(A) of the FD&C Act concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A, including the condition that drug products that are essentially copies of commercially available drug products not be compounded regularly or in inordinate amounts.

Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations.7

In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FD&C Act. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b)].

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.

E. Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

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. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.

Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (# 738238) and include a subject line that clearly identifies the submission as a Response to Warning Letter.

Sincerely,
/S/

Clint L. Narver, JD
Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

_________________________

1 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FD&C Act.

2 FDA considers a drug product to be commercially available if it is a marketed drug product.

3 FDA previously exercised enforcement discretion for state-licensed pharmacies compounding semaglutide and tirzepatide injection products that are essentially copies of commercially available drug products under section 503A. That enforcement discretion period ended with respect to tirzepatide injection products on March 5, 2025, and with respect to semaglutide injection products on April 24, 2025.

4 See, e.g., (b)(6).

5 The specific products made by your firm are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

6 Your ineligible drug products are not exempted from the requirements of section 502(f)(1) of the FD&C Act by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

7 In this letter we do not address whether your proposed corrective actions would resolve the CGMP violations noted above.

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