Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-06.
At a glance
Inspections
7
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Nov 2022 – 6 Dec 2022 | Human Drugs | 483 | View 483 → |
| 20 Jan 2020 – 24 Jan 2020 | Human Drugs | 483 | View 483 → |
| 8 Dec 2016 – 16 Dec 2016 | Human Drugs | 483 | On file |
| 11 Jun 2015 – 18 Jun 2015 | Human Drugs | Clean | |
| 27 Mar 2014 – 4 Apr 2014 | Human Drugs | Clean | |
| 17 Jul 2012 | Not recorded | 483 | On file |
| 11 Feb 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2022
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Nancy M Espinal
Investigators
FDA investigators tied to this site in the record.
Nancy M Espinal1 insp.
Andrew J Barrowcliff1 insp.
Daniel L Obrzut1 insp.
Nina Ni1 insp.
Christopher R Czajka1 insp.
Dennis Cantellops Paite1 insp.
James C Maclaughlin1 insp.
Constantin Y Philopoulos1 insp.
Timothy T Kapsala1 insp.
Charles Cote1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cenexi - Laboratoires Thissen Sa's 5 Form 483s
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