Polarean, Inc.
FDA inspection history in Durham, North Carolina, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Durham, North Carolina.
Cited most
Across all Polarean observations on file
- 21 CFR 820.30Design controls1
The complete Polarean file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Durham, North Carolina
One Form 483 · 2021 · 1 observation
Latest: Form 483, Sep 7, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-09-07 | 483 Form 483 | Durham, North Carolina | 1 | $99 |
Investigators on these documents
FEI number 3010132318 · most recent document Sep 7, 2021
About Polarean, Inc.
How many FDA Form 483s has Polarean, Inc. received?
FDA Intel has 1 Form 483 on file for Polarean, Inc.; the most recent is dated Sep 7, 2021.
When was Polarean, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Polarean, Inc. is a Form 483 dated Sep 7, 2021, for the site in Durham, North Carolina.
What did FDA cite at Polarean, Inc.?
The regulations cited most in the observations on file for Polarean, Inc. are 21 CFR 820.30 (Design controls), 1 time.