Antares Pharma, Inc.
Form 483 issued December 4, 2018 · Minnetonka, Minnesota
- Inspection
- Nov 27 – Dec 4, 2018
- Investigator
- Susan M. Matthias
- Observations
- 1
- Pages
- 3
- FEI number
- 2182861
In short: On December 4, 2018, FDA issued a Form 483 with 1 observation to Antares Pharma, Inc. in Minnetonka, Minnesota (FEI 2182861) after an inspection that ran Nov 27 – Dec 4, 2018. The investigator was Susan M. Matthias. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
This inspection in context
Susan M. Matthias
10 documents · 2013–2019
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmAntares Pharma, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Antares Pharma, Inc.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Antares Pharma, Inc.?
Susan M. Matthias is named on this Form 483, for the inspection of Nov 27 – Dec 4, 2018. Each investigator has a profile showing what they cite most.
When was Antares Pharma, Inc. inspected by FDA?
The inspection ran Nov 27 – Dec 4, 2018, and the Form 483 is dated December 4, 2018.
How do I get the full Form 483 for Antares Pharma, 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.