FDA Inspection 605234 — Glanbia Performance Nutrition, Inc
The FDA completed an inspection of Glanbia Performance Nutrition, Inc on September 4, 2009 in Sunrise, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sunrise, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15358 | FDCA 761(c)(1) | Timing of AE report submission (dietary supplement) |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |