Blue Bell Creameries, Inc.
Form 483 issued May 1, 2015 · Brenham, Texas
- Inspection
- Mar 16 – May 1, 2015
- Investigators
- Charles B. Steinmiller· Danielle Lyke· Denise Connelly
- Observations
- 6
- Pages
- 4
- FEI number
- 1682009
In short: On May 1, 2015, FDA issued a Form 483 with 6 observations to Blue Bell Creameries, Inc. in Brenham, Texas (FEI 1682009) after an inspection that ran Mar 16 – May 1, 2015. The investigators were Charles B. Steinmiller, Danielle Lyke, Denise Connelly, Franklin R. Harris, Frans E. Mercado, Habacuc V. Barrera, Hung V. Le, Jamie M. Bumpas, Massoud Motamed, Matthew R. Maddox and Shatina R. Alridge. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.35 (sanitary operations).
At a glance
6 of 6 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 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 manufacture foods under conditions and controls necessary to minimize the potential…
- 02
The procedure used for cleaning and sanitizing ofequipment has not been shown to provide adequate…
- 03
The plant is not constructed in such a manner as to prevent condensate from contaminating…
- 04
Failure to clean food-contact surfaces as frequently as necessary to…
This inspection in context
Charles B. Steinmiller
5 documents · 2015–2024
Cites 110.35 (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 110.35
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blue Bell Creameries, Inc.?
FDA listed 6 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 Blue Bell Creameries, Inc.?
Charles B. Steinmiller, Danielle Lyke, Denise Connelly, Franklin R. Harris, Frans E. Mercado, Habacuc V. Barrera, Hung V. Le, Jamie M. Bumpas, Massoud Motamed, Matthew R. Maddox and Shatina R. Alridge are named on this Form 483, for the inspection of Mar 16 – May 1, 2015. Each investigator has a profile showing what they cite most.
When was Blue Bell Creameries, Inc. inspected by FDA?
The inspection ran Mar 16 – May 1, 2015, and the Form 483 is dated May 1, 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.