Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-02-23.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2022 – 23 Feb 2022 | Foods & Cosmetics | 483 | View 483 → |
| 14 Dec 2017 – 21 Dec 2017 | Foods & Cosmetics | 483 | View 483 → |
| 16 Dec 2014 – 18 Dec 2014 | Foods & Cosmetics | 483 | View 483 → |
| 18 Feb 2011 | Not recorded | Clean | |
| 19 Nov 2009 | Not recorded | Clean | |
| 11 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2022
21 CFR 117.40
Equipment and utensils - Design and maintenance
Cited by Ismael Garibay, Anna L Viveros-Hernandez, Anna L Marroquin
23 Feb 2022
21 CFR 117.40
Equipment and utensils - Design and maintenance
Cited by Ismael Garibay, Anna L Viveros-Hernandez, Anna L Marroquin
23 Feb 2022
21 CFR 117.40
Equipment and utensils - Design and maintenance
Cited by Ismael Garibay, Anna L Viveros-Hernandez, Anna L Marroquin
Investigators
FDA investigators tied to this site in the record.
Ismael Garibay1 insp.
Anna L Viveros-Hernandez1 insp.
Anna L Marroquin1 insp.
Joseph M Willems1 insp.
Lucila B Nwatu1 insp.
Estefania Fernandez1 insp.
Cntrctmntr2 Lee1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.93 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(8) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Soojian, Inc. dba ak-mak Bakeries' 3 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