FDA Inspection 893997 — Iowa Select Herbs, L.L.C.
The FDA completed an inspection of Iowa Select Herbs, L.L.C. on August 28, 2014 in Cedar Rapids, IA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 28, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Cedar Rapids, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15976 | 21 CFR 111.123 | Quality control operations - master, batch, manufacturing |