Infusion Treatment Center Inc dba ITC Compounding
FDA inspection history across 2 sites, 2019 to 2020
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2020: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20One Form 483 and one warning letter, at Castle Rock, Colorado and Colorado.
Cited most
Across all Infusion Treatment Center Inc dba ITC Compounding observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Infusion Treatment Center Inc dba ITC Compounding file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Colorado
One warning letter · 2020
Latest: Warning letter, Aug 18, 2020 →Castle Rock, Colorado
One Form 483 · 2019 · 7 observations
Latest: Form 483, Jul 23, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-08-18 | Warning letter Warning letter | Colorado | — | $99 |
| 2019-07-23 | 483 Form 483 | Castle Rock, Colorado | 7 | $99 |
Investigators on these documents
FEI number 3008476140 · most recent document Aug 18, 2020
About Infusion Treatment Center Inc dba ITC Compounding
How many FDA Form 483s has Infusion Treatment Center Inc dba ITC Compounding received?
FDA Intel has 1 Form 483 on file for Infusion Treatment Center Inc dba ITC Compounding; the most recent is dated Jul 23, 2019.
When was Infusion Treatment Center Inc dba ITC Compounding last inspected by FDA?
The most recent FDA inspection document on file for Infusion Treatment Center Inc dba ITC Compounding is a Form 483 dated Jul 23, 2019, for the site in Castle Rock, Colorado.
What did FDA cite at Infusion Treatment Center Inc dba ITC Compounding?
The regulations cited most in the observations on file for Infusion Treatment Center Inc dba ITC Compounding are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Infusion Treatment Center Inc dba ITC Compounding received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Infusion Treatment Center Inc dba ITC Compounding; the most recent is dated Aug 18, 2020.