Overview
- 19 public-safe observations are available for this inspection.
- 19 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
HPHealth Pharma USA LLCRahway, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 19 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere