Tailstorm Health Inc.
FDA 503B outsourcing facility
Chandler, Arizona
Key Takeaways
- FDA-registered 503B outsourcing facility since 2019
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: May 23, 2025
- FDA action: Regulatory Meeting Held 11/18/2025
- 8 FDA drug recalls on record (2024 to 2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- October 23, 2019
- Most recent registration
- December 6, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- May 23, 2025
The FDA last inspected Tailstorm Health Inc. on May 23, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Regulatory Meeting Held 11/18/2025.
FDA recall history
Tailstorm Health Inc. has 8 FDA drug recalls on record between 2024 and 2025, based on the FDA enforcement database. Breakdown: 8 Class II.
Recall reasons on record include lack of assurance of sterility: a recent fda inspection revealed concerns with the; lack of sterility assurance; subpotent drug: reduced efficacy for epinephrine.
| Date | Class | Product | Reason |
|---|---|---|---|
| June 2025 | Class II | KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office U | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
| June 2025 | Class II | LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
| June 2025 | Class II | KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Onl | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
| June 2025 | Class II | BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Ner | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
| June 2025 | Class II | LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
Showing the 5 most recent of 8 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
Tailstorm Health Inc. reports compounding 12 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Semaglutide, Tirzepatide.
- Albuterol Sulfate
- Bevacizumab
- Epinephrine Bitartrate; Bupivacaine Hydrochloride
- Epinephrine Bitartrate; Lidocaine Hydrochloride
- Ketamine Hydrochloride
- Labetalol Hydrochloride
- Lidocaine Hydrochloride
- Lidocaine Hydrochloride; Epinephrine Bitartrate
- Lorazepam
- Semaglutide
- Tirzepatide
- Water
Location
24416 N 19th Ave Ste 200, Phoenix, AZ 85085-1400
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Contact
FDA-registered contact: Mitesh Gandhi, 480-274-8617. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Tailstorm Health Inc. with the Arizona State Board of Pharmacy.
503B facilities in Arizona
Tailstorm Health Inc. also operates a registered 503B facility at Phoenix, AZ.
Arizona has 3 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Arizona.
Frequently asked questions
Is Tailstorm Health Inc. registered with the FDA?
Yes. Tailstorm Health Inc. is a registered 503B outsourcing facility, first registered with the FDA on October 23, 2019 and most recently registered on December 6, 2025.
Has Tailstorm Health Inc. been inspected by the FDA?
The FDA last inspected Tailstorm Health Inc. on May 23, 2025. A Form FDA 483 was issued. FDA action on record: Regulatory Meeting Held 11/18/2025.
Has Tailstorm Health Inc. had any FDA drug recalls?
Tailstorm Health Inc. has 8 FDA drug recalls on record (2024 to 2025) in the FDA enforcement database.
What does Tailstorm Health Inc. compound?
Tailstorm Health Inc. reports compounding 12 active ingredients to the FDA, including Semaglutide, Tirzepatide.
Where is Tailstorm Health Inc. located?
Tailstorm Health Inc. is located in Chandler, Arizona (24416 N 19th Ave Ste 200).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Tailstorm Health Inc.. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.