Bidart
Form 483 issued January 6, 2015 · Shafter, California
- Inspection
- Dec 23, 2014 – Jan 6, 2015
- Investigators
- Estefania Fernandez· Joanne M. Fukuda· Steven M. Galvez
- Observations
- 1
- Pages
- 2
- FEI number
- 3010540230
In short: On January 6, 2015, FDA issued a Form 483 with 1 observation to Bidart in Shafter, California (FEI 3010540230) after an inspection that ran Dec 23, 2014 – 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 110.80 (processes and controls).
At a glance
1 of 1 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.80 (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
Food that has been prepared, packed, or held under insanitary conditions whereby it may have been…
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 firmBidart history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 110.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bidart?
FDA listed 1 observation on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.80 (processes and controls). The opening words of each observation are shown on this page.
Who inspected Bidart?
Estefania Fernandez, Joanne M. Fukuda and Steven M. Galvez are named on this Form 483, for the inspection of Dec 23, 2014 – Jan 6, 2015. Each investigator has a profile showing what they cite most.
When was Bidart inspected by FDA?
The inspection ran Dec 23, 2014 – Jan 6, 2015, and the Form 483 is dated January 6, 2015.
How do I get the full Form 483 for Bidart?
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.