Blue Bell Creameries, Inc.
FDA inspection history in Brenham, Texas, 2005 to 2016
- 7
- Responses
- 4
- EIRs
- 2
- Form 483s
Every document, by year
- Response
- Form 483
- EIR
2005: one inspection report; 2009: two 483 responses, one inspection report and one Form 483; 2010: one inspection report; 2012: one inspection report; 2015: five 483 responses and one Form 483; 2016: one fda_correspondence.
The story so far
Built from the dates and citations on the documents themselves.
- 2005One inspection report, at Brenham, Texas.
- 2009–12Three inspection reports, two 483 responses and one Form 483, at Brenham, Texas.
- 2015–16Five 483 responses, one Form 483 and one fda_correspondence, at Brenham, Texas.
- 2015The longest 483 on file: 6 observations over 4 pages at Brenham, Texas.
Cited most
Across all Blue Bell Creameries observations on file
- 21 CFR 110.35Sanitary operations3
- 21 CFR 110.80Processes and controls2
- 21 CFR 110.10Personnel1
- 21 CFR 110.20Plant and grounds1
The complete Blue Bell Creameries file.
All 13 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Brenham, Texas
Seven 483 responses, four inspection reports, two Form 483s and one fda_correspondence · 2005 to 2016 · 7 observations
Latest: Document, Feb 12, 2016 →
Documents
14 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-02-12 | fda_correspondence FDA document | Brenham, Texas | — | — |
| 2015-11-13 | Response 483 response | Brenham, Texas | — | $199 |
| 2015-08-28 | Response 483 response | Brenham, Texas | — | $199 |
| 2015-07-21 | Response 483 response | Brenham, Texas | — | $199 |
| 2015-07-21 | Response 483 response | Brenham, Texas | — | $199 |
| 2015-05-22 | Response 483 response | Brenham, Texas | — | $199 |
| 2015-05-01 | 483 Form 483 | Brenham, Texas | 6 | $99 |
| 2012-02-29 | EIR EIR | Brenham, Texas | — | $550 |
| 2010-05-12 | EIR EIR | Brenham, Texas | — | $550 |
| 2009-08-03 | Response 483 response | Brenham, Texas | — | $199 |
| 2009-07-30 | Response 483 response | Brenham, Texas | — | $199 |
| 2009-07-24 | EIR EIR | Brenham, Texas | — | $550 |
| 2009-07-24 | 483 Form 483 | Brenham, Texas | 1 | $99 |
| 2005-05-05 | EIR EIR | Brenham, Texas | — | $550 |
Investigators on these documents
Paul E. Frazier (3)R. Todd Lorenz (2)Denise Connelly (1)Franklin R. Harris (1)Frans E. Mercado (1)Habacuc V. Barrera (1)Hung V. Le (1)Jamie M. Bumpas (1)Lorie S. Hannappel (1)Massoud Motamed (1)Matthew R. Maddox (1)Robert T. Lorenz (1)
FEI number 1682009 · most recent document Feb 12, 2016
About Blue Bell Creameries, Inc.
How many FDA Form 483s has Blue Bell Creameries, Inc. received?
FDA Intel has 2 Form 483s on file for Blue Bell Creameries, Inc.; the most recent is dated May 1, 2015.
When was Blue Bell Creameries, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Blue Bell Creameries, Inc. is a Form 483 dated May 1, 2015, for the site in Brenham, Texas.
What did FDA cite at Blue Bell Creameries, Inc.?
The regulations cited most in the observations on file for Blue Bell Creameries, Inc. are 21 CFR 110.35 (Sanitary operations), 3 times; 21 CFR 110.80 (Processes and controls), 2 times; 21 CFR 110.10 (Personnel), 1 time.