Blue Bell Creameries Inc.
Form 483 issued April 30, 2015 · Sylacauga, Alabama
- Inspection
- Apr 6 – Apr 30, 2015
- Investigators
- Andrew F. Saunders· Justin N. Henson· Patrick C. Dooley
- Observations
- 8
- Pages
- 5
- FEI number
- 1019788
In short: On April 30, 2015, FDA issued a Form 483 with 8 observations to Blue Bell Creameries Inc. in Sylacauga, Alabama (FEI 1019788) after an inspection that ran Apr 6 – Apr 30, 2015. The investigators were Andrew F. Saunders, Justin N. Henson, Patrick C. Dooley, Thomas B. Smith and Wilvor K. Butler. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.40 (equipment and utensils).
At a glance
8 of 8 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.80 (2×) · 110.40(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to perform microbial testing where necessary to…
- 02
Suitable outer garments are not worn that protect against contamination of food…
- 03
Failure to maintain food contact surfaces to protect food from contamination by any source, including…
- 04
The design and materials of equipment and utensils does…
This inspection in context
Andrew F. Saunders
3 documents · 2009–2015
Cites 110.10 (personnel) more than any other section. Most of their documents are for sites in Tennessee.
The firmBlue Bell Creameries Inc. 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 Blue Bell Creameries Inc.?
FDA listed 8 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.40 (equipment and utensils). The opening words of each observation are shown on this page.
Who inspected Blue Bell Creameries Inc.?
Andrew F. Saunders, Justin N. Henson, Patrick C. Dooley, Thomas B. Smith and Wilvor K. Butler are named on this Form 483, for the inspection of Apr 6 – Apr 30, 2015. Each investigator has a profile showing what they cite most.
When was Blue Bell Creameries Inc. inspected by FDA?
The inspection ran Apr 6 – Apr 30, 2015, and the Form 483 is dated April 30, 2015.
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.