Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-18.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Oct 2025 – 18 Nov 2025 | Human Drugs | 483 | View 483 → |
| 17 Jun 2024 – 3 Jul 2024 | Human Drugs | 483 | View 483 → |
| 12 Dec 2022 – 20 Dec 2022 | Human Drugs | 483 | View 483 → |
| 17 Aug 2021 – 22 Sep 2021 | Human Drugs | 483 | View 483 → |
| 13 May 2019 – 3 Jun 2019 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Nov 2025
21 CFR 111.103
Written procedures - establish; quality control operations
Cited by Rose L Jean-Mary, Charlotte P Chang, Stephenie M Ortiz, Suchan Kim
18 Nov 2025
21 CFR 111.105(a)
Quality control - processes, specifications, written procedures
Cited by Rose L Jean-Mary, Charlotte P Chang, Stephenie M Ortiz, Suchan Kim
18 Nov 2025
21 CFR 111.10(b)
Hygienic practices
Cited by Rose L Jean-Mary, Charlotte P Chang, Stephenie M Ortiz, Suchan Kim
18 Nov 2025
21 CFR 111.153
Written procedures - follow; components
Cited by Rose L Jean-Mary, Charlotte P Chang, Stephenie M Ortiz, Suchan Kim
18 Nov 2025
21 CFR 111.155(e)
Components - contamination, deterioration, mix-ups
Cited by Rose L Jean-Mary, Charlotte P Chang, Stephenie M Ortiz, Suchan Kim
Investigators
FDA investigators tied to this site in the record.
Rose L Jean-Mary2 insp.
Suchan Kim2 insp.
Nicholas A Violand2 insp.
Monika Borkowska2 insp.
Charlotte P Chang1 insp.
Stephenie M Ortiz1 insp.
Annet R Rajan1 insp.
Andrew O Ejiofor1 insp.
Syeda N Mahazabin1 insp.
Anthony J Donato1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Health Pharma USA LLC's 5 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