Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
7 Aug 2023
21 CFR 111.140(a)
Records - QC operations: originals, copies, electronic
Cited by Erica B Raphael, Erica B Brush
7 Aug 2023
21 CFR 111.170
Quarantine component, package, labels, rejected product
Cited by Erica B Raphael, Erica B Brush
7 Aug 2023
21 CFR 111.403
Written procedures - labeling operations
Cited by Erica B Raphael, Erica B Brush
7 Aug 2023
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Erica B Raphael, Erica B Brush
Inspected site
ABAmerican BioSciences, Inc.Blauvelt, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.170 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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