Overview
- 8 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-10.
At a glance
Inspections
8
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2026 – 10 Mar 2026 | Human Drugs | 483 | View 483 → |
| 22 Mar 2022 – 1 Apr 2022 | Human Drugs | 483 | View 483 → |
| 24 Jan 2019 – 5 Feb 2019 | Human Drugs | 483 | On file |
| 23 May 2017 – 7 Jun 2017 | Human Drugs | 483 | On file |
| 4 Apr 2016 – 13 Apr 2016 | Human Drugs | 483 | On file |
| 2 Jun 2015 – 18 Jun 2015 | Human Drugs | 483 | View 483 → |
| 2 Jun 2015 – 11 Jun 2015 | Human Drugs | 483 | On file |
| 20 Feb 2013 – 7 Mar 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2026
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Angelica M Hernandez
1 Apr 2022
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
Investigators
FDA investigators tied to this site in the record.
Libia M Lugo3 insp.
Angelica M Hernandez2 insp.
Brian J Ryan2 insp.
Marian E Ramirez1 insp.
Alan A Rivera1 insp.
Ariel Cruz Figueroa1 insp.
Rebeca M Melendez1 insp.
Laurimer Kuilan-Torres1 insp.
Jose A Lopez Rubet1 insp.
Jose R Lopez1 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 | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NEOLPHARMA, INC.'s 8 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