Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-01-11.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jan 2019 – 11 Jan 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Apr 2015 – 5 Jun 2015 | Medical Devices & Rad Health | 483 | On file |
| 5 May 2014 – 27 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 May 2014 – 9 Jun 2014 | Medical Devices & Rad Health | 483 | On file |
| 27 Jun 2012 | Not recorded | WL | View 483 → |
| 8 May 2009 | Not recorded | 483 | View 483 → |
| 20 Mar 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jan 2019
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James A Lane, Juanj N Wu, Juanj Wu
11 Jan 2019
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James A Lane, Juanj N Wu, Juanj Wu
11 Jan 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by James A Lane, Juanj N Wu, Juanj Wu
11 Jan 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by James A Lane, Juanj N Wu, Juanj Wu
27 Jun 2014
21 CFR 820.30(c)
Design input - Lack of or inadequate procedures
Cited by Donna L Besone, Scott K Zika
Investigators
FDA investigators tied to this site in the record.
Scott K Zika4 insp.
Donna L Besone2 insp.
James A Lane1 insp.
Juanj N Wu1 insp.
Juanj Wu1 insp.
Joey V Quitania1 insp.
Shaquenta Y Perkins1 insp.
Yvette E Guillermo1 insp.
Cntrctmntr Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alere San Diego, Inc.'s 6 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