Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 20 Sep 2024 | Human Drugs | 483 | View 483 → |
| 8 Nov 2021 – 9 Nov 2021 | Human Drugs | Clean | |
| 9 Sep 2019 – 13 Sep 2019 | Human Drugs | Clean | |
| 4 Jan 2017 – 9 Jan 2017 | Human Drugs | 483 | View 483 → |
| 25 Jul 2016 – 29 Jul 2016 | Human Drugs | Clean | |
| 20 Jan 2015 – 21 Jan 2015 | Human Drugs | 483 | View 483 → |
| 21 Apr 2014 – 23 Apr 2014 | Human Drugs | Clean | |
| 4 Sep 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Anthony J Donato, Stephenie M Ortiz, Jenny Sung, Ifechimere I Okafor
9 Jan 2017
21 CFR 211.68(b)
Computer control of master formula records
Cited by Marcellinus D Dordunoo, Zakaria I Ganiyu
21 Jan 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Niketa Patel, Michael R Klapal
Investigators
FDA investigators tied to this site in the record.
Anthony J Donato1 insp.
Stephenie M Ortiz1 insp.
Jenny Sung1 insp.
Ifechimere I Okafor1 insp.
Michael Serrano1 insp.
Himanshu Gupta1 insp.
Peter R Lenahan1 insp.
Marcellinus D Dordunoo1 insp.
Zakaria I Ganiyu1 insp.
Gajendiran Mahadevan1 insp.
Niketa Patel1 insp.
Michael R Klapal1 insp.
Helen Verdel1 insp.
Liatte Krueger1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind RiconPharma LLC's 3 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