Overview
- 8 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Jun 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Nicholas A Violand, Monika Borkowska
3 Jun 2019
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Nicholas A Violand, Monika Borkowska
3 Jun 2019
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Nicholas A Violand, Monika Borkowska
3 Jun 2019
21 CFR 211.188(b)(8)
Labeling Control Records and Label Copies
Cited by Nicholas A Violand, Monika Borkowska
3 Jun 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicholas A Violand, Monika Borkowska
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 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | 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 8 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