503B Docket

IntegraDose Compounding Services, LLC 503B outsourcing facility · Shoreview, MN

This is a record of what FDA published, not a rating. Last FDA inspection and Form 483 status below are as published in FDA's registered outsourcing facilities table (as of Sep 30, 2026).

FDA registration record

Listed by FDA asIntegraDose Compounding Services, LLC, Shoreview, MN
City / stateShoreview, MN
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)1-612-672-6173
Initial registration date2/13/2026
Most recent registration date10/7/2026
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)8/12/2026
Form 483 issued at last inspection?Yes
Recall conducted? (FDA table)No
Action based on last inspectionOpen
“Open” means FDA has not determined whether further action will be taken (per FDA's table notes).
Intends to compound sterile drugs from bulk substancesYes
Self-reported by the facility at registration; FDA notes this information has not been verified by FDA.

Source: FDA Registered Outsourcing Facilities

Published FDA records

1Form 483 records
0Warning letters
2Recall events (openFDA)
12Uncertain-match items

Counts include only items from FDA's table or exact name + city + state matches. They are counts of published records, not a score. Uncertain matches are shown below but not counted.

State board of pharmacy license lookup

Minnesota Board of Pharmacy (board site)

Search the state board's lookup for this facility's license status and any disciplinary actions. We link to the state-level tool only and do not list license numbers. FDA's table does not include state board actions. Facilities that ship across state lines may also hold non-resident licenses in your state, so check your own state's board too.

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Timeline of FDA actions

Newest first. Sources: FDA's registration table, FDA's compounding actions page (2019 onward on the live page), and openFDA drug enforcement records. Items marked Uncertain match may relate to a different site or entity and are not counted. How matching works.

  1. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    No document link published · FDA registered outsourcing facilities table
  2. Form FDA 483 FDA table
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 08/12/2026 (PDF - 1.83MB)"). That listing is an uncertain match: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    FDA document · FDA registered outsourcing facilities table
  3. Recall Matched
    Recall event 99014
    Class II · Ongoing · 1 product line(s) · Recall no. D-0593-2026
    Recalling firm as listed: IntegraDose Compounding Services LLC, Shoreview, MN. Reason: Subpotent Drug
    openFDA record · openFDA drug enforcement API
  4. Recall Matched
    Recall event 98991
    Class II · Ongoing · 1 product line(s) · Recall no. D-0548-2026
    Recalling firm as listed: IntegraDose Compounding Services LLC, Shoreview, MN. Reason: Subpotent Drug
    openFDA record · openFDA drug enforcement API
  5. FMD-145 letter Uncertain match
    FMD-145 Letter Issued 3/26/2026
    Listed on FDA page under: IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  6. FMD-145 letter Uncertain match
    FMD-145 Letter Issued 3/25/2026
    Listed on FDA page under: IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  7. Recall Uncertain match
    Recall event 97641
    Class I · Ongoing · 1 product line(s) · Recall no. D-0015-2026
    Recalling firm as listed: IntegraDose Compounding Services LLC, Minneapolis, MN. Reason: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    openFDA record · openFDA drug enforcement API
  8. Form FDA 483 Uncertain match
    483 issued 07/25/2025 (PDF - 1,243 KB)
    Listed on FDA page under: IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  9. Regulatory meeting Uncertain match
    Regulatory Meeting Held 09/05/2024
    Listed on FDA page under: IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  10. Recall Uncertain match
    Recall event 94275
    Class II · Ongoing · 1 product line(s) · Recall no. D-0432-2024
    Recalling firm as listed: IntegraDose Compounding Services LLC, Minneapolis, MN. Reason: Lack of Assurance of Sterility: leaking bags
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    openFDA record · openFDA drug enforcement API
  11. Form FDA 483 Uncertain match
    483 Issued 03/01/2024 (PDF - 2.58MB)
    Listed on FDA page under: IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  12. Recall Uncertain match
    Recall event 93940
    Class II · Ongoing · 1 product line(s) · Recall no. D-0325-2024
    Recalling firm as listed: IntegraDose Compounding Services LLC, Minneapolis, MN. Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    openFDA record · openFDA drug enforcement API
  13. Recall Uncertain match
    Recall event 93829
    Class II · Ongoing · 1 product line(s) · Recall no. D-0258-2024
    Recalling firm as listed: IntegraDose Compounding Services LLC, Minneapolis, MN. Reason: Subpotent Drug
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    openFDA record · openFDA drug enforcement API
  14. Recall Uncertain match
    Recall event 88731
    Class II · Terminated · 2 product line(s) · Recall no. D-0896-2021, D-0897-2021
    Recalling firm as listed: IntegraDose Compounding Services LLC, Minneapolis, MN. Reason: Lack of sterility assurance.
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    openFDA record · openFDA drug enforcement API
  15. Form FDA 483 Uncertain match
    483 Issued 08/02/2021 (PDF - 1.12MB)
    Listed on FDA page under: IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  16. Warning letter Uncertain match
    Warning Letter (05/06/2020)
    Listed on FDA page under: IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility
    Why uncertain: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions

Possibly related FDA listings (uncertain)