Overview
- 13 public-safe observations are available for this inspection.
- 12 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.
15 Aug 2024
21 CFR 111.105(a)
Quality control - processes, specifications, written procedures
Cited by Gary C Pecic, Robert J Goldman, Vernon L O'Neil
15 Aug 2024
21 CFR 111.105(h)
Quality control - production, process control
Cited by Gary C Pecic, Robert J Goldman, Vernon L O'Neil
15 Aug 2024
21 CFR 111.110
Quality control - Laboratory control processes; production, process control
Cited by Gary C Pecic, Robert J Goldman, Vernon L O'Neil
15 Aug 2024
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Gary C Pecic, Robert J Goldman, Vernon L O'Neil
15 Aug 2024
21 CFR 111.205(a)
Master manufacturing record - prepared
Cited by Gary C Pecic, Robert J Goldman, Vernon L O'Neil
Inspected site
FCFX ChocolateDaytona Beach, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.110 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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