IntegraDose Compounding Services LLC
FDA inspection history across 2 sites, 2018 to 2026
- 5
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2018: one Form 483; 2020: one close-out letter; 2021: one Form 483; 2024: one Form 483; 2025: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–21Two Form 483s and one close-out letter, at Minneapolis, Minnesota.
- 2024–26Three Form 483s, at Minneapolis, Minnesota and Shoreview, Minnesota.
- 2024The longest 483 on file: 8 observations over 12 pages at Minneapolis, Minnesota.
Cited most
Across all IntegraDose Compounding Services observations on file
- 21 CFR 211.42Design and construction features9
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.192Production record review2
- 21 CFR 211.100(a)Written procedures; deviations1
The complete IntegraDose Compounding Services file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Minneapolis, Minnesota
Four Form 483s and one close-out letter · 2018 to 2025 · 24 observations
Latest: Form 483, Jul 25, 2025 →Shoreview, Minnesota
One Form 483 · 2026 · 4 observations
Latest: Form 483, Aug 12, 2026 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-12 | 483 Form 483 | Shoreview, Minnesota | 4 | $99 |
| 2025-07-25 | 483 Form 483 | Minneapolis, Minnesota | 6 | $99 |
| 2024-03-01 | 483 Form 483 | Minneapolis, Minnesota | 8 | $99 |
| 2021-08-02 | 483 Form 483 | Minneapolis, Minnesota | 4 | $99 |
| 2020-05-06 | Close-out Close-out letter | Minneapolis, Minnesota | — | $99 |
| 2018-09-19 | 483 Form 483 | Minneapolis, Minnesota | 6 | $99 |
Investigators on these documents
Kevin P. Regan (2)Emilie Kahn (1)Logan T. Williams (1)Mary-Jeanet McGarry (1)Melissa M. Steiger (1)Robert J. Ham (1)Ross J. Grigsby (1)Anthony Ladner (1)Sarah M. Gauna (1)
FEI number 3014483112 · most recent document Aug 12, 2026
About IntegraDose Compounding Services LLC
How many FDA Form 483s has IntegraDose Compounding Services LLC received?
FDA Intel has 5 Form 483s on file for IntegraDose Compounding Services LLC; the most recent is dated Aug 12, 2026.
When was IntegraDose Compounding Services LLC last inspected by FDA?
The most recent FDA inspection document on file for IntegraDose Compounding Services LLC is a Form 483 dated Aug 12, 2026, for the site in Shoreview, Minnesota.
What did FDA cite at IntegraDose Compounding Services LLC?
The regulations cited most in the observations on file for IntegraDose Compounding Services LLC are 21 CFR 211.42 (Design and construction features), 9 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.22 (Responsibilities of quality control unit), 5 times.