Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-14.
At a glance
Inspections
12
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Dec 2022 – 14 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 19 Mar 2018 – 23 Mar 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Aug 2016 – 19 Aug 2016 | Medical Devices & Rad Health | Clean | |
| 26 Oct 2012 | Not recorded | 483 | On file |
| 1 Oct 2010 | Not recorded | Clean | |
| 8 May 2009 | Not recorded | Clean | |
| 30 Sep 2005 | Not recorded | Clean | |
| 2 Dec 2004 | Not recorded | Clean | |
| 24 Aug 2004 | Not recorded | Clean | |
| 9 May 2003 | Not recorded | Clean | |
| 9 Aug 2001 | Not recorded | Clean | |
| 15 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Mar 2018
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Brandon L Mariner, Elizabeth B Griffin
23 Mar 2018
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Brandon L Mariner, Elizabeth B Griffin
23 Mar 2018
21 CFR 820.22
Quality Audits - defined intervals
Cited by Brandon L Mariner, Elizabeth B Griffin
23 Mar 2018
21 CFR 820.22
Quality Audits - defined intervals
Cited by Brandon L Mariner, Elizabeth B Griffin
23 Mar 2018
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Brandon L Mariner, Elizabeth B Griffin
Investigators
FDA investigators tied to this site in the record.
Andrew J Garufi2 insp.
Brandon L Mariner1 insp.
Elizabeth B Griffin1 insp.
Christian Parra1 insp.
Satheesh Thomas1 insp.
Sarah A Wangseng1 insp.
Ronald Ifraimov1 insp.
Stephanie Durso1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Chembio Diagnostics, Inc's 2 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