Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-17.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Apr 2024 – 17 Apr 2024 | Human Drugs | 483 | On file |
| 31 Jul 2023 – 4 Aug 2023 | Human Drugs | 483 | View 483 → |
| 25 Feb 2019 – 6 Mar 2019 | Human Drugs | 483 | On file |
| 3 Apr 2017 – 7 Apr 2017 | Human Drugs | 483 | On file |
| 31 Aug 2015 – 3 Sep 2015 | Human Drugs | Clean | |
| 23 Jun 2014 – 25 Jun 2014 | Human Drugs | Clean | |
| 3 Aug 2012 | Not recorded | Clean | |
| 13 Nov 2009 | Not recorded | 483 | On file |
| 14 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Aug 2023
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Dawn C Olenjack, Lakecha N Lewis
Investigators
FDA investigators tied to this site in the record.
Dipesh K Shah1 insp.
Guerlain Ulysse1 insp.
Dawn C Olenjack1 insp.
Lakecha N Lewis1 insp.
Sandra A Hughes1 insp.
Susanna E Ford1 insp.
Sandra A Boyd1 insp.
Libia M Lugo1 insp.
Dennis Cantellops Paite1 insp.
James C Maclaughlin1 insp.
Bonita S Chester1 insp.
Kham Phommachanh1 insp.
Jose A Lopez Rubet1 insp.
Ramon A Hernandez1 insp.
Guo Q Shen1 insp.
Tara R Gooen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 310.305(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Marksans Pharma Limited's 6 Form 483s
Source PDFs 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