Sanger Fresh Cut Produce Co. LLC
Form 483 issued October 26, 2010 · San Antonio, Texas
- Inspection
- Oct 14 – Oct 26, 2010
- Investigators
- Emilio O. Escobar· Erick G. Marchan· Kathleen Chmura Shaffer
- Observations
- 19
- Pages
- 8
- FEI number
- 2000036428
In short: On October 26, 2010, FDA issued a Form 483 with 19 observations to Sanger Fresh Cut Produce Co. LLC in San Antonio, Texas (FEI 2000036428) after an inspection that ran Oct 14 – Oct 26, 2010. The investigators were Emilio O. Escobar, Erick G. Marchan, Kathleen Chmura Shaffer and Rene R. Ramirez. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.10 (personnel).
At a glance
17 of 18 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.10 (4×) · 110.35 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to take necessary precautions to protect against contamination of food and food…
- 02
railure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects…
- 03
Employees did not wash hands thoroughly in an adequate hand-washing faciliry al any lime Iheir hands…
- 04
Pt:rsonnel with adverse health conditions are not instructed to…
This inspection in context
Emilio O. Escobar
1 document · 2010
Cites 110.10 (personnel) more than any other section. Most of their documents are for sites in Texas.
The firmSanger Fresh Cut Produce Co. LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 110.10
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sanger Fresh Cut Produce Co. LLC?
FDA listed 19 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.10 (personnel). The opening words of each observation are shown on this page.
Who inspected Sanger Fresh Cut Produce Co. LLC?
Emilio O. Escobar, Erick G. Marchan, Kathleen Chmura Shaffer and Rene R. Ramirez are named on this Form 483, for the inspection of Oct 14 – Oct 26, 2010. Each investigator has a profile showing what they cite most.
When was Sanger Fresh Cut Produce Co. LLC inspected by FDA?
The inspection ran Oct 14 – Oct 26, 2010, and the Form 483 is dated October 26, 2010.
How do I get the full Form 483 for Sanger Fresh Cut Produce Co. LLC?
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.