Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Oct 2020
21 CFR 117.4
Training of employees and records
Cited by Richard G Fochesato, Christopher W Milne
7 Oct 2020
21 CFR 123.6(c)(6)
Verification procedures - adequacy
Cited by Richard G Fochesato, Christopher W Milne
Inspected site
GNGrindstone Neck of Maine, LLCWinter Harbor, 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 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(6) | 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