Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-08-07.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Aug 2023 – 7 Aug 2023 | Foods & Cosmetics | 483 | View 483 → |
| 9 Jul 2019 – 11 Jul 2019 | Foods & Cosmetics | Clean | |
| 20 Jul 2016 – 25 Jul 2016 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 site report
Get the verbatim findings behind American BioSciences, Inc.'s 1 Form 483
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat