IntegraDose Compounding Services LLC
Form 483 issued September 19, 2018 · Minneapolis, Minnesota
- Inspection
- Sep 10 – Sep 19, 2018
- Investigator
- Emilie Kahn
- Observations
- 6
- Pages
- 8
- FEI number
- 3014483112
In short: On September 19, 2018, FDA issued a Form 483 with 6 observations to IntegraDose Compounding Services LLC in Minneapolis, Minnesota (FEI 3014483112) after an inspection that ran Sep 10 – Sep 19, 2018. The investigator was Emilie Kahn. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Test devices are deficient in that instruments not meeting…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected IntegraDose Compounding Services LLC?
Emilie Kahn is named on this Form 483, for the inspection of Sep 10 – Sep 19, 2018. Each investigator has a profile showing what they cite most.
When was IntegraDose Compounding Services LLC inspected by FDA?
The inspection ran Sep 10 – Sep 19, 2018, and the Form 483 is dated September 19, 2018.
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.