Overview
- 8 public-safe observations are available for this inspection.
- 6 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.
17 Sep 2024
21 CFR 117.35(b)(1)
Cleaning and sanitizing substances - Safe and adequate
Cited by Sonia E Ortiz
17 Sep 2024
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
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 | 3x |
| 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 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.42(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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