ITW Pro Brands
Form 483 issued April 1, 2022 · Olathe, Kansas
- Investigator
- Vaishali J. Patel
- Observations
- 6
- Pages
- 4
- FEI number
- 3001238779
In short: On April 1, 2022, FDA issued a Form 483 with 6 observations to ITW Pro Brands in Olathe, Kansas (FEI 3001238779). The investigator was Vaishali J. Patel. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and…
This inspection in context
Vaishali J. Patel
8 documents · 2019–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmITW Pro Brands history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ITW Pro Brands?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected ITW Pro Brands?
Vaishali J. Patel is named on this Form 483. Each investigator has a profile showing what they cite most.
When was ITW Pro Brands inspected by FDA?
This Form 483 is dated April 1, 2022.
How do I get the full Form 483 for ITW Pro Brands?
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.