Antares Pharma, Inc.
Form 483 issued May 13, 2022 · Minnetonka, Minnesota
- Investigator
- Brian D. Nicholson
- Observations
- 1
- Pages
- 3
- FEI number
- 2182861
In short: On May 13, 2022, FDA issued a Form 483 with 1 observation to Antares Pharma, Inc. in Minnetonka, Minnesota (FEI 2182861). The investigator was Brian D. Nicholson. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design change have…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 820.30
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 design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Antares Pharma, Inc.?
Brian D. Nicholson is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Antares Pharma, Inc. inspected by FDA?
This Form 483 is dated May 13, 2022.
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.