Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-18.
At a glance
Inspections
9
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Oct 2024 – 18 Oct 2024 | Human Drugs | 483 | View 483 → |
| 1 Jun 2021 – 9 Jun 2021 | Human Drugs | 483 | On file |
| 9 Oct 2018 – 24 Oct 2018 | Human Drugs | 483 | On file |
| 17 Nov 2015 – 23 Nov 2015 | Human Drugs | 483 | View 483 → |
| 29 Sep 2011 | Not recorded | 483 | View 483 → |
| 4 Jun 2010 | Not recorded | Clean | |
| 30 Jan 2009 | Not recorded | 483 | On file |
| 12 Nov 2008 | Not recorded | Clean | |
| 8 May 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2024
21 CFR 211.188(b)(12)
Investigations made into any unexplained discrepancy
Cited by Marian E Ramirez, Christian F Gomez Lugo
23 Nov 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Vilmary Negron Rodriguez, Ramon A Hernandez
Investigators
FDA investigators tied to this site in the record.
Ramon A Hernandez2 insp.
Jose R Lopez2 insp.
Marian E Ramirez1 insp.
Christian F Gomez Lugo1 insp.
Raquel Gonzalez Rivera1 insp.
Ariel Cruz Figueroa1 insp.
Libia M Lugo1 insp.
Vilmary Negron Rodriguez1 insp.
Rebecca Parrilla1 insp.
Jose E Melendez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Galephar Pharmaceutical Research Inc's 6 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