FDA Inspection 762388 — Wholistic Herbs, Inc.
The FDA completed an inspection of Wholistic Herbs, Inc. on January 10, 2012 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 10, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15405 | 21 CFR 111.13(a) | Supervisor - qualified |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15655 | 21 CFR 111.475(a) | Records - holding, distribution: 1 year, 2 years |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |