IntegraDose Compounding Services LLC
Form 483 issued July 25, 2025 · Minneapolis, Minnesota
- Inspection
- Jul 15 – Jul 25, 2025
- Investigator
- Logan T. Williams
- Observations
- 6
- Pages
- 6
- FEI number
- 3014483112
In short: On July 25, 2025, FDA issued a Form 483 with 6 observations to IntegraDose Compounding Services LLC in Minneapolis, Minnesota (FEI 3014483112) after an inspection that ran Jul 15 – Jul 25, 2025. The investigator was Logan T. Williams. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not written…
- 02
The statistical quality control criteria fail to…
- 03
Employees engaged in the manufacture and processing of a ding product lack the training required to…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IntegraDose Compounding Services LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected IntegraDose Compounding Services LLC?
Logan T. Williams is named on this Form 483, for the inspection of Jul 15 – Jul 25, 2025. Each investigator has a profile showing what they cite most.
When was IntegraDose Compounding Services LLC inspected by FDA?
The inspection ran Jul 15 – Jul 25, 2025, and the Form 483 is dated July 25, 2025.
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.