Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-04.
At a glance
Inspections
13
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Sep 2024 – 4 Oct 2024 | Medical Devices & Rad Health | 483 | On file |
| 11 Apr 2023 – 18 Apr 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Sep 2019 – 30 Sep 2019 | Medical Devices & Rad Health | Clean | |
| 11 Sep 2018 – 21 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Aug 2016 – 31 Aug 2016 | Medical Devices & Rad Health | 483 | On file |
| 6 Apr 2015 – 29 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2014 – 31 Jul 2014 | Medical Devices & Rad Health | WL | View 483 → |
| 13 May 2010 | Not recorded | Clean | |
| 13 May 2009 | Not recorded | WL | View 483 → |
| 10 Jan 2008 | Not recorded | 483 | On file |
| 6 Mar 2006 | Not recorded | Clean | |
| 29 Nov 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Apr 2023
21 CFR 820.70(d)
Personnel requirements, Lack of or inadequate requirements
Cited by Adaliz Santaliz-Cruz
Investigators
FDA investigators tied to this site in the record.
Adaliz Santaliz-Cruz3 insp.
Monica C Burgos Garcia2 insp.
Laiza V Garcia2 insp.
Wanda J Torres2 insp.
Nydia E Colon1 insp.
Sean T Creighton1 insp.
Rafael Gonzalez1 insp.
Miguel G Manzano1 insp.
Jose F Pedro De Jesus1 insp.
Marilyn Santiago1 insp.
Luis A Carrion1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.130 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Customed, Inc.'s 8 Form 483s
Source PDFs, 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