Polarean, Inc.
Form 483 issued September 7, 2021 · Durham, North Carolina
- Inspection
- Aug 30 – Sep 7, 2021
- Investigator
- David E. Lowe
- Observations
- 1
- Pages
- 4
- FEI number
- 3010132318
In short: On September 7, 2021, FDA issued a Form 483 with 1 observation to Polarean, Inc. in Durham, North Carolina (FEI 3010132318) after an inspection that ran Aug 30 – Sep 7, 2021. The investigator was David E. Lowe. 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
The design was not validated using initial production units, lots or…
This inspection in context
David E. Lowe
1 document · 2021
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmPolarean, Inc. history
The site's inspection history, in date order.
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 Polarean, 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 Polarean, Inc.?
David E. Lowe is named on this Form 483, for the inspection of Aug 30 – Sep 7, 2021. Each investigator has a profile showing what they cite most.
When was Polarean, Inc. inspected by FDA?
The inspection ran Aug 30 – Sep 7, 2021, and the Form 483 is dated September 7, 2021.
How do I get the full Form 483 for Polarean, 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.