Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-19.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2023 – 19 May 2023 | Human Drugs | Clean | |
| 24 May 2021 – 4 Jun 2021 | Human Drugs | Clean | |
| 9 Mar 2020 – 11 Mar 2020 | Human Drugs | Clean | |
| 17 Feb 2020 – 25 Feb 2020 | Human Drugs | 483 | On file |
| 22 Jul 2019 – 30 Jul 2019 | Human Drugs | Clean | |
| 9 Oct 2017 – 17 Oct 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2020
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Alan P Kurtzberg, Lixia Cai
25 Feb 2020
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Alan P Kurtzberg, Lixia Cai
17 Oct 2017
21 CFR 211.188(b)(13)
Results of drug product inspections and examinations
Cited by Junho Pak
Investigators
FDA investigators tied to this site in the record.
Hasan A Irier1 insp.
MRA DavisM1 insp.
Sripal R Mada1 insp.
Alan P Kurtzberg1 insp.
Lixia Cai1 insp.
Sangeeta M Khurana1 insp.
Susanna E Ford1 insp.
Junho Pak1 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 | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Rafarm S.A.'s 2 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