Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
24 Jan 2020
21 CFR 111.103
Written procedures - quality control operations
Cited by Shannon A Lowe, Khunnathee Stoner
24 Jan 2020
21 CFR 111.403
Written procedures - labeling operations
Cited by Shannon A Lowe, Khunnathee Stoner
24 Jan 2020
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Shannon A Lowe, Khunnathee Stoner
24 Jan 2020
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Shannon A Lowe, Khunnathee Stoner
24 Jan 2020
21 CFR 111.70(d)
Specifications - labels, packaging
Cited by Shannon A Lowe, Khunnathee Stoner
Inspected site
ACAmerican Chinese Natural Herbs, Inc.Garland, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | 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(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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