IntegraDose Compounding Services, LLC
FDA 503B outsourcing facility
Shoreview, Minnesota
Key Takeaways
- FDA-registered 503B outsourcing facility since 2026
- Sterile compounding from bulk substances: Yes
- Not yet inspected by the FDA
- 7 FDA drug recalls on record (2021 to 2026)
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
- February 13, 2026
- Most recent registration
- February 13, 2026
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- Not yet inspected
IntegraDose Compounding Services, LLC has registered with the FDA as a 503B outsourcing facility but has not yet been inspected. The FDA inspects registered facilities on a risk-based schedule once drug production and distribution are confirmed.
FDA recall history
IntegraDose Compounding Services, LLC has 7 FDA drug recalls on record between 2021 and 2026, based on the FDA enforcement database. Breakdown: 1 Class I, 6 Class II.
Recall reasons on record include subpotent drug; subpotent drug: testing revealed there was no oxytocin in the iv bag; lack of assurance of sterility: leaking bags; sub-potent drug: failure to maintain potency through the duration of the labeled; lack of sterility assurance.
| Date | Class | Product | Reason |
|---|---|---|---|
| May 2026 | Class II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Su | Subpotent Drug |
| September 2025 | Class I | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minn | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. |
| March 2024 | Class II | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minnea | Lack of Assurance of Sterility: leaking bags |
| January 2024 | Class II | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota | Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date. |
| January 2024 | Class II | Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1 | Subpotent Drug |
Showing the 5 most recent of 7 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
IntegraDose Compounding Services, LLC reports compounding 9 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Oxytocin.
- Cefazolin Sodium
- Epinephrine; Bupivacaine Hydrochloride
- Fentanyl Citrate
- Hydromorphone Hydrochloride
- Oxytocin
- Phenylephrine Hydrochloride
- Ropivacaine Hydrochloride; Fentanyl Citrate
- Sugammadex
- Vasopressin, Unspecified
Location
3650 Victoria St N Ste 900, Shoreview, MN 55126-2906
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Contact
FDA-registered contact: Craig Else, 1-612-672-6173. 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 IntegraDose Compounding Services, LLC with the Minnesota Board of Pharmacy.
503B facilities in Minnesota
Frequently asked questions
Is IntegraDose Compounding Services, LLC registered with the FDA?
Yes. IntegraDose Compounding Services, LLC is a registered 503B outsourcing facility, first registered with the FDA on February 13, 2026 and most recently registered on February 13, 2026.
Has IntegraDose Compounding Services, LLC been inspected by the FDA?
IntegraDose Compounding Services, LLC has registered with the FDA but has not yet been inspected as a 503B outsourcing facility.
Has IntegraDose Compounding Services, LLC had any FDA drug recalls?
IntegraDose Compounding Services, LLC has 7 FDA drug recalls on record (2021 to 2026) in the FDA enforcement database.
What does IntegraDose Compounding Services, LLC compound?
IntegraDose Compounding Services, LLC reports compounding 9 active ingredients to the FDA, including Oxytocin.
Where is IntegraDose Compounding Services, LLC located?
IntegraDose Compounding Services, LLC is located in Shoreview, Minnesota (3650 Victoria St N Ste 900).
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 IntegraDose Compounding Services, LLC. 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.