Federal Package Network, Inc.
Form 483 issued February 17, 2017 · Chanhassen, Minnesota
- Inspection
- Feb 13 – Feb 17, 2017
- Investigator
- Anthony Ladner
- Observations
- 2
- Pages
- 2
- FEI number
- 3003152994
In short: On February 17, 2017, FDA issued a Form 483 with 2 observations to Federal Package Network, Inc. in Chanhassen, Minnesota (FEI 3003152994) after an inspection that ran Feb 13 – Feb 17, 2017. The investigator was Anthony Ladner. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.150 (distribution procedures).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.150(b) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The distribution system is deficient in that each lot of drug product cannot be readily determined…
- 02
Employees are not given training in…
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 firmFederal Package Network, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.150(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Federal Package Network, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.150 (distribution procedures). The opening words of each observation are shown on this page.
Who inspected Federal Package Network, Inc.?
Anthony Ladner is named on this Form 483, for the inspection of Feb 13 – Feb 17, 2017. Each investigator has a profile showing what they cite most.
When was Federal Package Network, Inc. inspected by FDA?
The inspection ran Feb 13 – Feb 17, 2017, and the Form 483 is dated February 17, 2017.
How do I get the full Form 483 for Federal Package Network, Inc.?
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.