Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-07.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Feb 2024 – 7 Feb 2024 | Foods & Cosmetics | 483 | View 483 → |
| 23 Aug 2021 – 24 Aug 2021 | Foods & Cosmetics | 483 | View 483 → |
| 17 Apr 2018 – 20 Apr 2018 | Foods & Cosmetics | 483 | View 483 → |
| 13 Jul 2015 – 16 Jul 2015 | Foods & Cosmetics | 483 | View 483 → |
| 13 Nov 2013 – 14 Nov 2013 | Foods & Cosmetics | 483 | On file |
| 8 Oct 2010 | Not recorded | 483 | On file |
| 17 Jun 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Feb 2024
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Ciara J Bajulai Austin, Patricia P Wrona
24 Aug 2021
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Jessica I Newman, Brenda Chavez
24 Aug 2021
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Jessica I Newman, Brenda Chavez
20 Apr 2018
21 CFR 117.40
Equipment and Utensils - Design and Maintenance
Cited by Christopher M Jenner
Investigators
FDA investigators tied to this site in the record.
John A Daubenspeck2 insp.
Ciara J Bajulai Austin1 insp.
Patricia P Wrona1 insp.
Jessica I Newman1 insp.
Brenda Chavez1 insp.
Christopher M Jenner1 insp.
Michelle J Hines1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Azteca Bakeries, Incorporated's 6 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat