Overview
- 9 public-safe observations are available for this inspection.
- 8 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.
6 May 2026
21 CFR 117.35(b)(1)
Cleaning and sanitizing substances - Safe and adequate
Cited by Sonia E Ortiz
6 May 2026
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Sonia E Ortiz
6 May 2026
21 CFR 1250.33(a)
Adequate facilities for cleaning, bactericidal treatment
Cited by Sonia E Ortiz
6 May 2026
21 CFR 1250.42(b)
Connections easily cleanable, located and protected
Cited by Sonia E Ortiz
Inspected site
HCHornBlower Cruises and Events LLCNew York, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1250.67 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.82(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, 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