Form 483 · FEI 3010520230
Form 483 issued January 6, 2015 · Shafter, California
- Inspection
- Jan 6, 2015
- Investigators
- Estefania Fernandez· Joanne M. Fukuda· Steven M. Galvez
- Observations
- 2
- Pages
- 2
- FEI number
- 3010520230
In short: On January 6, 2015, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Shafter, California (FEI 3010520230) after an inspection that ran Jan 6, 2015. The investigators were Estefania Fernandez, Joanne M. Fukuda and Steven M. Galvez. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.35 (sanitary operations).
At a glance
2 of 2 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.35 (1×) · 110.40 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
On 12/23/14, we collected sample INV 870215, consisting of 110 environmental swabs collected from food and…
- 02
On 12/23/14, we observed direct food contact areas of packaging equipment, used during the 2014 apple…
This inspection in context
Estefania Fernandez
10 documents · 2009–2015
Cites 118.4 (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 110.35
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.35 (sanitary operations). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Estefania Fernandez, Joanne M. Fukuda and Steven M. Galvez are named on this Form 483, for the inspection of Jan 6, 2015. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jan 6, 2015, and the Form 483 is dated January 6, 2015.
How do I get the full Form 483 for an FDA-inspected site?
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.