Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-11-25.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2019 – 25 Nov 2019 | Human Drugs | 483 | View 483 → |
| 5 Nov 2017 – 13 Nov 2017 | Human Drugs | 483 | On file |
| 25 Sep 2016 – 29 Sep 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Nov 2019
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Saied A Asbagh
Investigators
FDA investigators tied to this site in the record.
Saied A Asbagh1 insp.
Jose O Hernandez1 insp.
Wendy G Tan1 insp.
Marion Michaelis1 insp.
Sharon K Thoma1 insp.
Sharon K Pederson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Rafa Laboratories Ltd.'s 3 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