Compounded with
Semaglutide
Not verified in the bound record.
Tirzepatide
Not verified in the bound record.
Product evidence does not establish current availability.
Pharmacy evidence record · researched 2026-08-20
FarmaKeio network entities include Farmakeio Outsourcing LLC and North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Not verified in the bound record.
Not verified in the bound record.
Product evidence does not establish current availability.
Regulatory compliance
A pathway label describes which federal rules apply — it is not a quality claim.
Section 503A
FDA's action index labels this exact network entity a 503A facility. Section 503A is statutory and is not FDA facility registration.
Section 503B
FDA's action index labels the exact Southlake entity a 503B facility, and an FDA warning letter documents registration as an outsourcing facility. The most recent weekly registry row/date was not recovered.
Telehealth providers
Clinic Scout links a provider only when an explicit source names the relationship.
Regulatory history
FDA warning-letter, closeout, Form 483, compounding-action and current-registry sources were checked. State-board action searches were not exhaustive.
U.S. Food and Drug Administration · 2021-07-29
FDA stated that products failed to meet all conditions of section 503B and cited unapproved and misbranded drug-product violations.
issued_current_closeout_unverifiedU.S. Food and Drug Administration · 2022-11-18
FDA cited serious sterile-production deficiencies and insanitary conditions; FDA later stated that the firm appeared to have adequately addressed the warning-letter violations.
closed_out_2026-01-27U.S. Food and Drug Administration · 2025-09-05
FDA listed five inspection observations concerning investigations, laboratory controls, release testing, equipment qualification and calibration. A Form 483 records inspectional observations and is not a final agency determination.
issuedNo Clinic Scout patient reviews are published for this pharmacy. Submissions go through manual moderation before anything appears here.
What this record verifies for you
Each line traces to a citation in the source list below — read the exact captured wording before relying on it.
No superiority claim is made for review volume, ratings, or patient sentiment.
Discover a 503B pharmaceutical outsourcing facility dedicated to the achievement of the highest standards in the industry.
FarmaKeio Custom Compounding is licensed in the following states:
Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility
North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX – 503A Facility
You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act
During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.
Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance.
GLP Clinic Scout does not issue a blanket legitimacy verdict. This research record preserves 8 dated first-party or regulator citation(s), 3 regulatory/action record(s), and 6 explicitly unresolved field(s). Review the cited evidence and current license status before making a decision.
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