PolarityTE, Inc.
Form 483 issued July 13, 2018 · Salt Lake City, Utah
- Inspection
- Jul 9 – Jul 13, 2018
- Investigators
- Kelly D. Moore· Scott Ballard· Travis S. Bradley
- Observations
- 8
- Pages
- 5
- FEI number
- 3014453293
In short: On July 13, 2018, FDA issued a Form 483 with 8 observations to PolarityTE, Inc. in Salt Lake City, Utah (FEI 3014453293) after an inspection that ran Jul 9 – Jul 13, 2018. The investigators were Kelly D. Moore, Scott Ballard and Travis S. Bradley. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Kelly D. Moore
2 documents · 2008–2018
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Utah.
The firmPolarityTE, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PolarityTE, Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected PolarityTE, Inc.?
Kelly D. Moore, Scott Ballard and Travis S. Bradley are named on this Form 483, for the inspection of Jul 9 – Jul 13, 2018. Each investigator has a profile showing what they cite most.
When was PolarityTE, Inc. inspected by FDA?
The inspection ran Jul 9 – Jul 13, 2018, and the Form 483 is dated July 13, 2018.
How do I get the full Form 483 for PolarityTE, 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.