2026-09-18 FDA Warning Letter: Empower Clinic Services, LLC dba Empower Pharmacy Cited for CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
TL;DR
In short: FDA Warning Letter cgmp: Empower Clinic Services, LLC dba Empower Pharmacy — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (2026-09-18). Entities: Empower Clinic Services, LLC dba Empower Pharmacy.
Argus analysis
FDA issued a Warning Letter to Empower Clinic Services, LLC dba Empower Pharmacy (matter: Empower Clinic Services, LLC dba Empower Pharmacy — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (2026-09-18)). The verbatim letter is published on fda.gov; the page below links to the original source record.
The classification token assigned to this matter is "cgmp". Citations and 21 CFR sections referenced in the letter are available in the original FDA document — see the source link.
Warning Letters typically include a 15-business-day response window. Compliance teams in the same industry often review the issuing office and the cited 21 CFR sections to map read-across against their own quality systems.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Empower Clinic Services, LLC dba Empower Pharmacy MARCS-CMS 738238 — September 18, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Conditi…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- Is the FDA warning letter to Empower Clinic Services, LLC dba Empower Pharmacy publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-09-18 FDA Warning Letter: Empower Clinic Services, LLC dba Empower Pharmacy Cited for CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-empower-clinic-services-llc-dba-empower-pharmacy-2026-09-18-cgmp
"2026-09-18 FDA Warning Letter: Empower Clinic Services, LLC dba Empower Pharmacy Cited for CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-empower-clinic-services-llc-dba-empower-pharmacy-2026-09-18-cgmp.
Argus HQ Research. "2026-09-18 FDA Warning Letter: Empower Clinic Services, LLC dba Empower Pharmacy Cited for CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug." Digital Empire Holdings LLC. Accessed September 27, 2026. https://argushq.ai/fda/warning-letter/fda-wl-empower-clinic-services-llc-dba-empower-pharmacy-2026-09-18-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_empower_clinic_services_llc_dba_empower_pharmacy_2026_09_18_cgmp_2026,
title = {2026-09-18 FDA Warning Letter: Empower Clinic Services, LLC dba Empower Pharmacy Cited for CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-empower-clinic-services-llc-dba-empower-pharmacy-2026-09-18-cgmp},
note = {Accessed: September 27, 2026}
}