Whisk Products, Inc.
Form 483 issued October 22, 2021 · Wentzville, Missouri
- Inspection
- Oct 18 – Oct 22, 2021
- Investigator
- Logan T. Williams
- Observations
- 7
- Pages
- 5
- FEI number
- 1000056584
In short: On October 22, 2021, FDA issued a Form 483 with 7 observations to Whisk Products, Inc. in Wentzville, Missouri (FEI 1000056584) after an inspection that ran Oct 18 – Oct 22, 2021. The investigator was Logan T. Williams. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
The written stability program for drug products does not describe the storage conditions for…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmWhisk Products, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Whisk Products, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Whisk Products, Inc.?
Logan T. Williams is named on this Form 483, for the inspection of Oct 18 – Oct 22, 2021. Each investigator has a profile showing what they cite most.
When was Whisk Products, Inc. inspected by FDA?
The inspection ran Oct 18 – Oct 22, 2021, and the Form 483 is dated October 22, 2021.
How do I get the full Form 483 for Whisk Products, 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.