PolarityTE, Inc.
FDA inspection history in Salt Lake City, Utah, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Salt Lake City, Utah.
Cited most
Across all PolarityTE observations on file
- 21 CFR 211.42(a)Design and construction features4
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete PolarityTE file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Salt Lake City, Utah
One Form 483 · 2018 · 8 observations
Latest: Form 483, Jul 13, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-07-13 | 483 Form 483 | Salt Lake City, Utah | 8 | $99 |
Investigators on these documents
FEI number 3014453293 · most recent document Jul 13, 2018
About PolarityTE, Inc.
How many FDA Form 483s has PolarityTE, Inc. received?
FDA Intel has 1 Form 483 on file for PolarityTE, Inc.; the most recent is dated Jul 13, 2018.
When was PolarityTE, Inc. last inspected by FDA?
The most recent FDA inspection document on file for PolarityTE, Inc. is a Form 483 dated Jul 13, 2018, for the site in Salt Lake City, Utah.
What did FDA cite at PolarityTE, Inc.?
The regulations cited most in the observations on file for PolarityTE, Inc. are 21 CFR 211.42(a) (Design and construction features), 4 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(a) (General requirements), 1 time.