FDA Inspection 987402 — Black Seed Herb Inc.
The FDA completed an inspection of Black Seed Herb Inc. on September 21, 2016 in Liberty, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 21, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Liberty, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15604 | 21 CFR 111.165(b) | Product received - visually examine invoice, guarantee, cert |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |