Heartland I.V. Care
Form 483 issued July 14, 2017 · Saint Paul, Minnesota
- Inspection
- Jul 10, 2017
- Investigators
- Anthony Ladner· James K. Ireland
- Observations
- 1
- Pages
- 1
- FEI number
- 3013576855
In short: On July 14, 2017, FDA issued a Form 483 with 1 observation to Heartland I.V. Care in Saint Paul, Minnesota (FEI 3013576855) after an inspection that ran Jul 10, 2017. The investigators were Anthony Ladner and James K. Ireland. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Sporicidal agents are not used in your faci lity's cleanrooms…
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 firmHeartland I.V. Care history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Heartland I.V. Care?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Heartland I.V. Care?
Anthony Ladner and James K. Ireland are named on this Form 483, for the inspection of Jul 10, 2017. Each investigator has a profile showing what they cite most.
When was Heartland I.V. Care inspected by FDA?
The inspection ran Jul 10, 2017, and the Form 483 is dated July 14, 2017.
How do I get the full Form 483 for Heartland I.V. Care?
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.