FDA Inspection 657113 — Glanbia Performance Nutrition
The FDA completed an inspection of Glanbia Performance Nutrition on April 15, 2010 in Aurora, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 15, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15934 | 21 CFR 111.105(c) | Quality control - basis; in-process, component, specifications |
| 15966 | 21 CFR 111.117(a) | Quality control operations - calibrating processes |
| 16051 | 21 CFR 111.525(b) | Returned dietary supplement - release |
| 16066 | 21 CFR 111.35(b)(1)(i) | Written procedures - instruments, controls; calibrating |