FDA Inspection 1213031 — American BioSciences, Inc.
The FDA completed an inspection of American BioSciences, Inc. on August 7, 2023 in Blauvelt, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Blauvelt, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15614 | 21 CFR 111.170 | Quarantine component, package, labels, rejected product |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16010 | 21 CFR 111.140(a) | Records - QC operations: originals, copies, electronic |