Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
14 Aug 2023
21 CFR 111.30(c)
Equipment - automated - calibrate, inspect
Cited by Khunnathee Stoner, Micmarie Ramos, Micmarie Ramos Rodriguez
14 Aug 2023
21 CFR 111.535(b)(1)
Records - returned dietary supplement: written procedures
Cited by Khunnathee Stoner, Micmarie Ramos, Micmarie Ramos Rodriguez
14 Aug 2023
21 CFR 111.70(d)
Specifications - labels, packaging
Cited by Khunnathee Stoner, Micmarie Ramos, Micmarie Ramos Rodriguez
14 Aug 2023
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Khunnathee Stoner, Micmarie Ramos, Micmarie Ramos Rodriguez
14 Aug 2023
21 CFR 111.75(c)(1)
Specifications met - verify; production, process control
Cited by Khunnathee Stoner, Micmarie Ramos, Micmarie Ramos Rodriguez
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 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(1) | 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