Techni Med, Inc. dba The Compounder
Form 483 issued October 10, 2019 · Aurora, Illinois
- Inspection
- Sep 23 – Oct 10, 2019
- Investigator
- James K. Ireland
- Observations
- 5
- Pages
- 3
- FEI number
- 3004504906
In short: On October 10, 2019, FDA issued a Form 483 with 5 observations to Techni Med, Inc. dba The Compounder in Aurora, Illinois (FEI 3004504906) after an inspection that ran Sep 23 – Oct 10, 2019. The investigator was James K. Ireland. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 2 systems, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (2×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 02FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
You used a non-pharmaceutical grade component in the formulation…
This inspection in context
James K. Ireland
10 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmTechni Med, Inc. dba The Compounder history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Techni Med, Inc. dba The Compounder?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Techni Med, Inc. dba The Compounder?
James K. Ireland is named on this Form 483, for the inspection of Sep 23 – Oct 10, 2019. Each investigator has a profile showing what they cite most.
When was Techni Med, Inc. dba The Compounder inspected by FDA?
The inspection ran Sep 23 – Oct 10, 2019, and the Form 483 is dated October 10, 2019.
How do I get the full Form 483 for Techni Med, Inc. dba The Compounder?
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.