FDA Inspection 755134 — Reaction Nutrition LLC
The FDA completed an inspection of Reaction Nutrition LLC on December 20, 2011 in Carnegie, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 20, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Carnegie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |