IntegraDose Compounding Services LLC
Form 483 issued August 12, 2026 · Shoreview, Minnesota
- Inspection
- Aug 4 – Aug 12, 2026
- Investigators
- Mary-Jeanet McGarry· Sarah M. Gauna
- Observations
- 4
- Pages
- 9
- FEI number
- 3014483112
In short: On August 12, 2026, FDA issued a Form 483 with 4 observations to IntegraDose Compounding Services LLC in Shoreview, Minnesota (FEI 3014483112) after an inspection that ran Aug 4 – Aug 12, 2026. The investigators were Mary-Jeanet McGarry and Sarah M. Gauna. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Mary-Jeanet McGarry
3 documents · 2016–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmIntegraDose Compounding Services LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IntegraDose Compounding Services LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected IntegraDose Compounding Services LLC?
Mary-Jeanet McGarry and Sarah M. Gauna are named on this Form 483, for the inspection of Aug 4 – Aug 12, 2026. Each investigator has a profile showing what they cite most.
When was IntegraDose Compounding Services LLC inspected by FDA?
The inspection ran Aug 4 – Aug 12, 2026, and the Form 483 is dated August 12, 2026.
How do I get the full Form 483 for IntegraDose Compounding Services LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.