FDA Inspection 849137 — Herbalife Manufacturing, LLC
The FDA completed an inspection of Herbalife Manufacturing, LLC on Sep 11, 2013 in Lake Forest, CA. 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). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lake Forest, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1090 | 21 CFR 110.40(d) | Holding, conveying, mfg systems - design & construction |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 1702 | 21 CFR 110.80(b)(8) | Metal / extraneous materials |
| 3062 | 21 CFR 114.10 | Personnel |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3083 | 21 CFR 114.89 | Process deviation evaluation |
| 4464 | 21 CFR 108.25(c)(1) | Registration |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4477 | 21 CFR 108.25(d) | Reporting to FDA |
| 4479 | 21 CFR 108.25(e) | Recall procedures |
| 985 | 21 CFR 110.10(b)(1) | Suitable outer garments |