Infusion Treatment Center Inc dba ITC Compounding
Form 483 issued July 23, 2019 · Castle Rock, Colorado
- Inspection
- Jul 12 – Jul 23, 2019
- Investigator
- Zachary A. Bogorad
- Observations
- 7
- Pages
- 6
- FEI number
- 3008476140
In short: On July 23, 2019, FDA issued a Form 483 with 7 observations to Infusion Treatment Center Inc dba ITC Compounding in Castle Rock, Colorado (FEI 3008476140) after an inspection that ran Jul 12 – Jul 23, 2019. The investigator was Zachary A. Bogorad. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced highly potent drugs without providing adequate containment, segregation, cleaning of work smfaces and cleaning…
- 02
Non-microbial contamination was observed…
- 03
You used a non-pharmaceutical grade component in the formulation…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Zachary A. Bogorad
12 documents · 2011–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmInfusion Treatment Center Inc dba ITC Compounding history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Infusion Treatment Center Inc dba ITC Compounding?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Infusion Treatment Center Inc dba ITC Compounding?
Zachary A. Bogorad is named on this Form 483, for the inspection of Jul 12 – Jul 23, 2019. Each investigator has a profile showing what they cite most.
When was Infusion Treatment Center Inc dba ITC Compounding inspected by FDA?
The inspection ran Jul 12 – Jul 23, 2019, and the Form 483 is dated July 23, 2019.
How do I get the full Form 483 for Infusion Treatment Center Inc dba ITC Compounding?
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.