Overview
- 24 public-safe observations are available for this inspection.
- 12 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.
1 Dec 2017
21 CFR 111.205(b)(1)
Master manufacturing record - specifications; quality
Cited by Elizabeth D Connell
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 108.25(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.77(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.95(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.80(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.89 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 24 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