Overview
- 22 public-safe observations are available for this inspection.
- 9 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.
25 Mar 2019
21 CFR 111.105(c)
Basis; in-process, component, specifications
Cited by Charles B Steinmiller
25 Mar 2019
21 CFR 111.105(c)
Basis; in-process, component, specifications
Cited by Charles B Steinmiller
25 Mar 2019
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Charles B Steinmiller
Inspected site
ANAegle Nutrition LLCCarrollton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.95(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.105(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.10 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.83 | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 22 observations
Every observation in full, 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