KL Distributing 16034 Us Highway 19
Form 483 issued October 27, 2022 · Hudson, Florida
- Inspection
- Oct 24 – Oct 27, 2022
- Investigator
- Stanley B. Eugene
- Observations
- 2
- Pages
- 5
- FEI number
- 3004183512
In short: On October 27, 2022, FDA issued a Form 483 with 2 observations to KL Distributing 16034 Us Highway 19 in Hudson, Florida (FEI 3004183512) after an inspection that ran Oct 24 – Oct 27, 2022. The investigator was Stanley B. Eugene. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.50 (1×) · 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Procedures for training and identifying training needs…
This inspection in context
Stanley B. Eugene
6 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Florida.
The firmKL Distributing 16034 Us Highway 19 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KL Distributing 16034 Us Highway 19?
FDA listed 2 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected KL Distributing 16034 Us Highway 19?
Stanley B. Eugene is named on this Form 483, for the inspection of Oct 24 – Oct 27, 2022. Each investigator has a profile showing what they cite most.
When was KL Distributing 16034 Us Highway 19 inspected by FDA?
The inspection ran Oct 24 – Oct 27, 2022, and the Form 483 is dated October 27, 2022.
How do I get the full Form 483 for KL Distributing 16034 Us Highway 19?
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.