FDA Inspection 728068 — JW Nutritional LLC
The FDA completed an inspection of JW Nutritional LLC on May 19, 2011 in Allen, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 19, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Allen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15535 | 21 CFR 111.255(d) | Batch record - 1 year, 2 years |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15576 | 21 CFR 111.155(a) | Visually examine - containers |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15586 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15597 | 21 CFR 111.160(c)(3) | Labels - quality control; approve, release |
| 15615 | 21 CFR 111.180(a) | Records - components, packaging, labels, product received: |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |