FDA Inspection 679656 — Herbal Extracts Plus, LLC
The FDA completed an inspection of Herbal Extracts Plus, LLC on Sep 16, 2010 in Bensalem, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bensalem, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15461 | 21 CFR 111.20(d)(1)(iii) | Physical plant - ventilation, environmental control |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15778 | 21 CFR 111.415(b) | Dietary supplement - protect, contamination |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |