IntegraDose Compounding Services LLC
Form 483 issued March 1, 2024 · Minneapolis, Minnesota
- Inspection
- Feb 12 – Mar 1, 2024
- Investigators
- Kevin P. Regan· Melissa M. Steiger· Robert J. Ham
- Observations
- 8
- Pages
- 12
- FEI number
- 3014483112
In short: On March 1, 2024, FDA issued a Form 483 with 8 observations to IntegraDose Compounding Services LLC in Minneapolis, Minnesota (FEI 3014483112) after an inspection that ran Feb 12 – Mar 1, 2024. The investigators were Kevin P. Regan, Melissa M. Steiger and Robert J. Ham. 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 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Kevin P. Regan
7 documents · 2021–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Minnesota.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IntegraDose Compounding Services LLC?
FDA listed 8 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?
Kevin P. Regan, Melissa M. Steiger and Robert J. Ham are named on this Form 483, for the inspection of Feb 12 – Mar 1, 2024. Each investigator has a profile showing what they cite most.
When was IntegraDose Compounding Services LLC inspected by FDA?
The inspection ran Feb 12 – Mar 1, 2024, and the Form 483 is dated March 1, 2024.
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.