Overview
- 19 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Nov 2019
21 CFR 111.570(b)(1)
Written procedures - product complaint; review, investigate
Cited by Kenneth Boehnen
7 Nov 2019
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Kenneth Boehnen
Inspected site
HPHawaii Pharm LLCHonolulu, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.95(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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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