IntegraDose Compounding Services LLC
Form 483 issued August 2, 2021 · Minneapolis, Minnesota
- Inspection
- Jul 12 – Aug 2, 2021
- Investigators
- Anthony Ladner· Kevin P. Regan· Ross J. Grigsby
- Observations
- 4
- Pages
- 6
- FEI number
- 3014483112
In short: On August 2, 2021, FDA issued a Form 483 with 4 observations to IntegraDose Compounding Services LLC in Minneapolis, Minnesota (FEI 3014483112) after an inspection that ran Jul 12 – Aug 2, 2021. The investigators were Anthony Ladner, Kevin P. Regan and Ross J. Grigsby. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of diug products purporting to be sterile are not established…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Anthony Ladner
10 documents · 2016–2022
Cites 211.113 (control of microbiological contamination) 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 211.113(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 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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?
Anthony Ladner, Kevin P. Regan and Ross J. Grigsby are named on this Form 483, for the inspection of Jul 12 – Aug 2, 2021. Each investigator has a profile showing what they cite most.
When was IntegraDose Compounding Services LLC inspected by FDA?
The inspection ran Jul 12 – Aug 2, 2021, and the Form 483 is dated August 2, 2021.
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.