Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
13 Nov 2025
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Austin B Appler, Mohamad A Chahine, Karen A Spencer
13 Nov 2025
21 CFR 117.35(a)
Sanitary operations - Plant sanitation
Cited by Austin B Appler, Mohamad A Chahine, Karen A Spencer
13 Nov 2025
21 CFR 117.80(c)
Manufacturing, processing, packing, holding - Controls
Cited by Austin B Appler, Mohamad A Chahine, Karen A Spencer
Inspected site
TCThe Coastal Companies DBA Hearn KirkwoodJessup, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 4 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