Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Mar 2025
21 CFR 117.4
Qualifications of individuals
Cited by Yen-Tso Kuo, Angelica Ornelas, Trusten J Robles
27 Mar 2025
21 CFR 123.11(b)
Sanitation monitoring
Cited by Yen-Tso Kuo, Angelica Ornelas, Trusten J Robles
27 Mar 2025
21 CFR 123.12(a)(2)
Importer verification
Cited by Yen-Tso Kuo, Angelica Ornelas, Trusten J Robles
27 Mar 2025
21 CFR 123.6(b)
HACCP plan implementation
Cited by Yen-Tso Kuo, Angelica Ornelas, Trusten J Robles
27 Mar 2025
21 CFR 123.6(c)(2)
Critical control points
Cited by Yen-Tso Kuo, Angelica Ornelas, Trusten J Robles
Inspected site
HMHARBOR MARINE PRODUCT, INC.Vernon, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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