Overview
- 10 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.
17 Mar 2022
21 CFR 111.103
Written procedure quality control operations material review
Cited by Khunnathee Stoner, Kristin N Longfellow
17 Mar 2022
21 CFR 111.255(a)
Batch record - every batch
Cited by Khunnathee Stoner, Kristin N Longfellow
17 Mar 2022
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Khunnathee Stoner, Kristin N Longfellow
17 Mar 2022
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Khunnathee Stoner, Kristin N Longfellow
17 Mar 2022
21 CFR 111.70(d)
Specifications - labels, packaging
Cited by Khunnathee Stoner, Kristin N Longfellow
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 111.70(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | 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 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 10 observations
The source PDF, 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