Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-05.
At a glance
Inspections
8
Form 483s
4
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2025 – 5 Jun 2025 | Human Drugs | Clean | |
| 11 Jan 2023 – 20 Jan 2023 | Human Drugs | 483 | View 483 → |
| 23 Oct 2019 – 1 Nov 2019 | Human Drugs | 483 | View 483 → |
| 23 Aug 2016 – 31 Aug 2016 | Human Drugs | Clean | |
| 8 Jun 2015 – 11 Jun 2015 | Human Drugs | 483 | View 483 → |
| 15 Jan 2013 | Not recorded | Clean | |
| 7 May 2012 | Not recorded | 483 | On file |
| 15 Feb 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Jan 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jose F Velez, Marian E Ramirez, Alan A Rivera
20 Jan 2023
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Jose F Velez, Marian E Ramirez, Alan A Rivera
11 Jun 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by German Rivera, Ariel Cruz Figueroa
11 Jun 2015
21 CFR 211.42(b)
Adequate space lacking to prevent mix-ups and contamination
Cited by German Rivera, Ariel Cruz Figueroa
Investigators
FDA investigators tied to this site in the record.
Marian E Ramirez4 insp.
Libia M Lugo2 insp.
Jose F Velez1 insp.
Alan A Rivera1 insp.
Vilmary Negron Rodriguez1 insp.
German Rivera1 insp.
Ariel Cruz Figueroa1 insp.
Laiza V Garcia1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Galephar Pharmaceutical Research Inc.'s 4 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