Best Sanitizers, Inc.
Form 483 issued October 16, 2015 · Walton, Kentucky
- Inspection
- Oct 5 – Oct 16, 2015
- Investigators
- Lauren N. Smith· Lindsey M. Schwierjohann
- Observations
- 7
- Pages
- 4
- FEI number
- 3005763425
In short: On October 16, 2015, FDA issued a Form 483 with 7 observations to Best Sanitizers, Inc. in Walton, Kentucky (FEI 3005763425) after an inspection that ran Oct 5 – Oct 16, 2015. The investigators were Lauren N. Smith and Lindsey M. Schwierjohann. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
The batch production and control records are deficient in that they do not include documentation…
- 04
Procedures describing the handling of all written and oral complaints regarding a drug product…
This inspection in context
Lauren N. Smith
3 documents · 2015–2016
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmBest Sanitizers, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Best Sanitizers, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Best Sanitizers, Inc.?
Lauren N. Smith and Lindsey M. Schwierjohann are named on this Form 483, for the inspection of Oct 5 – Oct 16, 2015. Each investigator has a profile showing what they cite most.
When was Best Sanitizers, Inc. inspected by FDA?
The inspection ran Oct 5 – Oct 16, 2015, and the Form 483 is dated October 16, 2015.
How do I get the full Form 483 for Best Sanitizers, 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.