Blue Bell Creameries, Inc.
Form 483 issued July 24, 2009 · Brenham, Texas
- Inspection
- Jul 23 – Jul 24, 2009
- Investigators
- Paul E. Frazier· Todd Lorenz
- Observations
- 1
- Pages
- 1
- FEI number
- 1682009
In short: On July 24, 2009, FDA issued a Form 483 with 1 observation to Blue Bell Creameries, Inc. in Brenham, Texas (FEI 1682009) after an inspection that ran Jul 23 – Jul 24, 2009. The investigators were Paul E. Frazier and Todd Lorenz. 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×)
What FDA observed
Preview: the opening words of each observation- 01
All reasonable precautions are not taken to ensure that production procedures do not contribute…
This inspection in context
Paul E. Frazier
7 documents · 2009–2011
Cites 110.35(a) (sanitary operations) more than any other section. Most of their documents are for sites in Texas.
The firmBlue Bell Creameries, Inc. history
All 14 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 Blue Bell Creameries, Inc.?
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 Blue Bell Creameries, Inc.?
Paul E. Frazier and Todd Lorenz are named on this Form 483, for the inspection of Jul 23 – Jul 24, 2009. Each investigator has a profile showing what they cite most.
When was Blue Bell Creameries, Inc. inspected by FDA?
The inspection ran Jul 23 – Jul 24, 2009, and the Form 483 is dated July 24, 2009.
How do I get the full Form 483 for Blue Bell Creameries, Inc.?
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.