Spakinect

Spakinect Discover the simplicity of our virtual good faith evaluations for medical spas. SpaKinect is a physician-owned Medical Corporation.

Our practitioners are compassionate and knowledgeable with expertise in the field of TeleHealth Medicine. We aim to provide excellence in quality, service, and support. SpaKinect offers the most robust TeleHealth solution on the market with proven success in the wellness center industry. Whether you’re starting a new telehealth program, increasing the scope of your current program, or simply want

an effective, low-cost telemonitoring alternative, our Integrated Practitioner Services provide targeted, compassionate care that decreases wellness center costs and improves your patient’s visit. SpaKinect provides expert Telehealth practitioners that operate as a natural extension of your coordinated approval program. We serve as an integrated care team and combine the strengths of your local wellness center team with SpaKinect's centralized Telemedical expertise. The result is a highly effective, efficient, and scalable Telehealth program. SpaKinect can serve as your back-office, integrate your wellness approval protocols in our video conferencing and sophisticated electronic medical record software, and even generate approval letters in real time. By leveraging the latest breakthroughs in information technology, SpaKinect provides Telehealth and "cloud computing" systems with unparalleled advantages for wellness center medical professionals and clinicians. Our systems are designed to produce a digital standardized medical approval record that significantly reduces the cost of running medical wellness centers. Your clinic deserves knowledgeable and compassionate practitioners. From Start to Finish, your experience with SpaKinect will be simple, affordable and stress-free! SpaKinect's Telehealth practitioner experts can help you achieve your program outcome and ROI goals!

09/01/2026

Most practices aren't taking enough follow-up photos. That becomes a problem when a patient is unhappy with their results.

We sat down with Leslie Fletcher, MSN, RN, AGNP-BC — educator, trainer, and thought leader in medical aesthetics — who's seen it play out plenty of times. Patients come in disappointed, but there's always a picture in their head that doesn't match the mirror. Pull up two clinical images side by side and the conversation changes.

What Leslie's describing is really about having a record. Photos capture the outcome. Documentation captures everything that led up to it — what the patient wanted, what was recommended, and what they agreed to. Both give you something solid to point to when memory and reality don't line up. That's the part we handle at Spakinect.

How do you use before-and-afters in your practice? Tell us in the comments!

🚨 A nationwide IV saline recall just went out over possible fiberglass. Here are the two lot numbers to check.On August ...
08/28/2026

🚨 A nationwide IV saline recall just went out over possible fiberglass. Here are the two lot numbers to check.

On August 26, 2026, the FDA published Baxter's voluntary nationwide recall of two lots of 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX, over the potential presence of fiberglass particulate matter. Baxter initiated the recall on August 25 and has directed customers to stop using affected units immediately and return them.

What to look for:
→ Lot numbers — Y495523 and Y495523A
→ Product code — 2B1323Q
→ NDC — 0338-0049-03
→ Expiration — October 31, 2027

The affected units were distributed July 31 through August 3 to healthcare providers and distributors in Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, and Virginia. Product moves between facilities, so it's worth checking your inventory even if you're outside those states.

Why it matters: fiberglass particulate in an IV solution enters the bloodstream directly. Baxter's announcement lists potential effects including vascular blockage or clotting, pulmonary embolism, organ damage, vein irritation, inflammatory reactions, and allergic reactions. As of August 25, Baxter reported no adverse events associated with the recalled lots.

What to do now:
→ Pull your IV inventory and check for the product code and both lot numbers
→ Stop using any affected units and return them per Baxter's instructions
→ Tell your clinical staff and anyone who pulls supplies
→ Document what you found, removed, and returned
→ Report any adverse reaction or quality problem through the FDA's MedWatch program

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/baxter-sodium-chloride-injection-recall-potential-fiberglass

🚨 Eli Lilly is suing a Med Spa over alleged black-market sales of an unapproved drug.On August 12, 2026, Eli Lilly annou...
08/26/2026

🚨 Eli Lilly is suing a Med Spa over alleged black-market sales of an unapproved drug.

On August 12, 2026, Eli Lilly announced six federal lawsuits against U.S. businesses it alleges sold products represented as retatrutide. The cases span federal courts in California and Texas. Lilly characterized the products as part of an illegal market for the drug.

Who was sued:
→ A Med Spa, named among the six defendants
→ Four peptide sellers marketing peptide products online
→ A compounding pharmacy

Lilly also reports referring more than 200 individuals and entities to the FDA, the Department of Justice, state attorneys general, and professional licensing boards, and flagging more than 14,000 listings across over 100 countries.

All six lawsuits are pending. The allegations have not been proven.

Why retatrutide is different: this isn't a compounded version of an approved drug. Retatrutide is still in Phase 3 clinical trials for obesity, type 2 diabetes, and related conditions. It has no FDA approval for human use, and the FDA has stated it cannot lawfully be compounded. Lilly alleges some sellers used "research-use only" positioning despite intending the products for human use.

With semaglutide and tirzepatide, the question was sourcing. We've covered imported peptides in Michigan, compounded GLP-1 advertising in Connecticut, and FDA warning letters over marketing claims. Retatrutide is a different category. The drug itself isn't lawfully available at all.

How to protect your Med Spa:
→ Confirm any drug you offer is lawfully available and appropriately sourced
→ Check whether a product is FDA-approved, compounded, or investigational before it enters your practice
→ Review supplier claims about product identity and regulatory status
→ Keep marketing and patient-facing materials aligned with lawful drug pathways
→ Document pharmacy, supplier, prescription, and product information for weight-management services

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/eli-lilly-retatrutide-black-market-lawsuits

🚨 A company sold an unapproved botulinum toxin called "Scalpatox." The CEO just took 4 to 8 years.On July 31, 2026, the ...
08/25/2026

🚨 A company sold an unapproved botulinum toxin called "Scalpatox." The CEO just took 4 to 8 years.

On July 31, 2026, the U.S. Attorney's Office for the Western District of Virginia announced that the CEO of a skincare company pleaded guilty in a federal case involving an unapproved botulinum toxin product and unapproved devices sold between 2018 and 2020. He agreed to a prison term of four to eight years, restitution, and $800,000 in forfeiture.

The products in the case:

→ Scalpatox — a botulinum toxin product for injection, with no FDA-approved drug application
→ Fibroblast Pen — a device using high-frequency current on the skin, without FDA clearance
→ Hyaluron Pen — a needle-free device for delivering fillers, without FDA clearance
→ ScalpaJECT — a hyaluronic acid product marketed as a dermal filler

The 2024 indictment charged 34 federal counts: 12 mail fraud, 9 wire fraud, 12 involving adulterated devices, and 1 involving an unapproved new drug. He pleaded guilty to three and agreed he committed all 34.

An unapproved toxin and uncleared devices were marketed straight to the aesthetics space. The company represented that the devices weren't subject to FDA regulation, and that claim didn't hold.

How to protect your Med Spa:
→ Confirm whether each product you use is regulated by the FDA as a drug or a device
→ Verify FDA approval or clearance status before stocking any injectable or device
→ Check the manufacturer, supplier, and distribution source for what you inject and use
→ Treat "not FDA-regulated" supplier claims as a reason to verify, not accept

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/skincare-ceo-virginia-botulinum-toxin-unapproved-device-case

🚨 The FDA just updated the pathway for generic Ozempic, Wegovy, and Mounjaro.On July 28, 2026, the FDA published 17 revi...
08/24/2026

🚨 The FDA just updated the pathway for generic Ozempic, Wegovy, and Mounjaro.

On July 28, 2026, the FDA published 17 revised draft guidances for companies developing generic peptide drugs. The documents cover semaglutide, tirzepatide, and liraglutide products, and they set out what the agency expects from a generic application.

The drugs on the list:
→ Semaglutide: Ozempic, Wegovy
→ Tirzepatide: Mounjaro, Zepbound
→ Liraglutide: Victoza, Saxenda
Plus calcitonin salmon, glucagon, teriparatide, and other peptide products.

What's changed: the FDA revised what a generic peptide application must show, covering areas like impurity thresholds, immune response testing, and biological activity assessment. The agency also withdrew its 2021 peptide guidance and plans to replace it later this year.

What hasn't changed: no generic GLP-1 has been approved. The guidances remain in draft form. Prescribing, sourcing, and compounding requirements stay exactly where they were.

Public comments are open through September 28, 2026.

This sits alongside a busy year of GLP-1 activity we've tracked, from the FDA's warning letters to telehealth companies to the July review of seven peptides for the 503A Bulks List. Different pathways, same underlying question of what's approved and what isn't.

What Med Spas should do:
→ Keep tracking FDA activity on generic GLP-1 and peptide development
→ Know the difference between FDA-approved, compounded, and non-approved products in your inventory
→ Confirm your suppliers, distributors, and pharmacies are properly authorized
→ Keep prescribing, sourcing, and marketing aligned with current federal and state rules

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/fda-generic-glp1-peptide-drug-development-guidance

🚨 New microneedling depth rules are already in effect. Do your device settings match?Indiana HB 1131 expanded the statut...
08/20/2026

🚨 New microneedling depth rules are already in effect. Do your device settings match?

Indiana HB 1131 expanded the statutory definition of an esthetician, effective July 1, 2026. Microneedling had never been defined in Indiana Code, leaving estheticians to work from interpretation. The bill adds a definition, along with eyelash lifting and tinting and eyebrow lamination and tinting.

What changed:
Before, Indiana Code had no definition of microneedling. Whether an esthetician could perform it depended on depth and whether it crossed into practicing medicine.

Now, the statute defines it as a cosmetic procedure using fine needles at a pe*******on depth of at least 0.3mm and no greater than 2mm. Indiana operators finally have a number to point to.

What this changes for Med Spas:
→ Federal rules run alongside state law. The FDA regulates certain microneedling products as devices based on intended use.
→ Training documentation is required. Practitioners must keep proof of advanced training or certification.
→ It's producible on request. The Indiana Professional Licensing Agency can ask to see it.
→ Indiana isn't alone. Kentucky's Board of Nursing tied microneedling scope to depth in June 2026.

How to protect your Med Spa:
→ Check what depth your microneedling devices are actually set to
→ Confirm anyone performing microneedling is licensed and working inside the defined depth range
→ Keep proof of advanced training or certification for every practitioner who offers it
→ Confirm whether a Good Faith Exam is required for the depths your practice treats at

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/indiana-hb-1131-esthetician-electrology-scope

🚨 These GLP-1s were sold as "research use only." Prosecutors called them misbranded drugs and the seller got 21 months.O...
08/18/2026

🚨 These GLP-1s were sold as "research use only." Prosecutors called them misbranded drugs and the seller got 21 months.

On July 23, 2026, a federal judge in the Western District of Michigan sentenced a man to 21 months in prison for conspiring to introduce misbranded drugs into the market. Prosecutors reported he sold imported peptides, semaglutide, and tirzepatide from China through websites describing the products as intended for research purposes only.

What was missing:
→ No prescription — semaglutide and tirzepatide require one from a licensed practitioner before they can be dispensed
→ No directions for use — shipments went out without them, which is what makes a drug misbranded under FDA regulations
→ No boxed warning — FDA-approved versions carry one addressing the risk of thyroid C-cell tumors
→ No accurate origin — products were represented as "Product of the USA" after being purchased from China

If your Med Spa carries products with the research-use designation, it's worth understanding precisely what it does and doesn't do. Prescription requirements stay in place either way. Actual intended use is what governs, and sentencing filings stated the seller knew customers intended personal use. Labeling still has to carry adequate directions, and federal law prohibits introducing misbranded drugs into interstate commerce under 21 U.S.C. § 331(a).

How to protect your Med Spa:
→ Verify the source, manufacturer, and distribution pathway for every peptide and GLP-1 product
→ Confirm an authorized provider is involved wherever a prescription is required
→ Review labeling, warnings, directions for use, and country of origin before stocking anything
→ Understand the designation each product carries and what it means for how you use it

Know what you're holding, where it came from, and what's required before it reaches a patient.

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/michigan-federal-peptide-glp1-drug-sentencing

08/17/2026

A GFE is only as strong as its provider. So we invest in ours.

We recently brought our provider team together at our Annual Virtual Retreat for a day of learning, connecting, and investing in the people behind every Spakinect exam.

A huge thank you to everyone who made this experience so meaningful:

→ Nazli () for helping us recharge through yoga
→ Dr. Andrew Brandeis () from for sharing clinical education
→ Dr. Allan Churukian for guiding us through the standards our providers practice by

This is what our W-2 model makes possible. Our providers are an invested team that keeps learning, growing, and showing up for the 4,500+ Med Spas that trust us.

Trained. Passionate. Always learning. 💜

🚨 A Peptide Supplier Forged Its Lab Certificates and Sold to 54,000 Customers. The Owner Got Nearly 6 Years.On July 30, ...
08/14/2026

🚨 A Peptide Supplier Forged Its Lab Certificates and Sold to 54,000 Customers. The Owner Got Nearly 6 Years.

On July 30, 2026, a federal court in the Northern District of Indiana sentenced the owner of an online peptide company to 70 months in prison for selling unapproved drugs, including products labeled "research use only" that were marketed for human use. An employee received 16 months. Both were ordered to pay $78,317 in restitution.

Prosecutors estimated the company reached about 54,000 customers across all 50 states and 80 countries between 2019 and 2024, continuing even after two FDA warning letters.

What was claimed versus what was real:
→ "Made in the USA" — products were imported from China, India, and elsewhere
→ "Third-party lab-tested" — the owner admitted the certificates were forged
→ "Safe and verified" — the products were unapproved by the FDA
→ Sold as SARMs — federal testing found they contained testosterone, a controlled substance

When sourcing happens through unregulated channels, the marketing and the reality can drift far apart. And when they do, the people at risk are the patients who trusted the claims.

This was an online seller, not a Med Spa. But it's one of the pathways peptide products reach a practice, and the questions worth asking are the same:
→ Sourcing — where do the products come from, and who's between the manufacturer and your clinic?
→ Documentation — can you trace a certificate of analysis back to the lab that issued it?
→ Approval status — do you know the designation each product carries and what it means for your practice?
→ Provider oversight — is a licensed provider deciding whether a peptide fits a specific patient?

With peptides, your supplier's compliance becomes your compliance.

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/federal-peptide-seller-unapproved-drug-sentence

🚨 This Med Spa is accused of ordering drugs on an APRN's credentials after they resigned. The Board suspended its drug l...
08/12/2026

🚨 This Med Spa is accused of ordering drugs on an APRN's credentials after they resigned. The Board suspended its drug license.

On June 1, 2026, the Ohio Board of Pharmacy summarily suspended the drug distributor license of a combined Med Spa and chiropractic clinic in Lewis Center, Ohio. The suspension followed two inspections and an investigation into the clinic's drug sourcing, prescriber authorization, storage, and records.

What the Board alleges:
→ APRNs' prescriber credentials were used to order NAD and sermorelin without authorization, including after one resigned and while another was outside the country
→ Medications were provided without documented prescriber orders
→ Medications returned by one patient were later provided to another
→ Peptides were received from a supplier lacking required U.S. distribution credentials

The clinic was given 30 days to request a hearing. As of this reporting, the license remains suspended, and all claims remain allegations.

Here's what makes this case matter for every Med Spa: if you purchase, store, or administer regulated drugs, you may fall under pharmacy-board oversight, not just medical-board rules. We saw similar credential and authorization issues in the Iowa and Arizona cases we covered. Who's authorized, and whether it's documented, keeps driving enforcement.

How to protect your Med Spa:
→ Verify every drug supplier's credentials before purchasing regulated medications
→ Tie every medication order to a valid, authorized prescriber
→ Keep documented prescriber orders for every regulated drug used in patient care
→ Secure on-site medications under proper access, temperature, and expiration controls
→ Maintain inventories, purchasing records, and administration logs for inspection

When your Med Spa handles medications, sourcing, authorization, and records are the compliance backbone.

💡 Follow Spakinect for more industry insights designed specifically for Med Spa owners.

To read the full article, visit: https://www.spakinect.com/news/ohio-med-spa-chiropractic-drug-distributor-license-suspension

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