Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-07-21.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2011 | Not recorded | WL | View 483 → |
| 10 Jun 2011 | Not recorded | 483 | View 483 → |
| 6 Apr 2011 | Not recorded | 483 | On file |
| 2 Mar 2011 | Not recorded | 483 | On file |
| 24 Jun 2010 | Not recorded | 483 | View 483 → |
| 18 Dec 2008 | Not recorded | 483 | View 483 → |
| 16 Dec 2008 | Not recorded | 483 | On file |
| 5 Dec 2006 | Not recorded | Clean | |
| 5 Apr 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Joanne E King3 insp.
State Agency3 insp.
James T O Neal2 insp.
Karen M Rodriguez1 insp.
Kelly M Byers1 insp.
Beira Montalvo1 insp.
Jennifer Caycedo1 insp.
Jason P Aun1 insp.
M A Abel I1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.10 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(c)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind E and M Bakery, Inc.'s 7 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