FDA Inspection 797656 — The Muscadine Group, LLC
The FDA completed an inspection of The Muscadine Group, LLC on September 5, 2012 in Pine Level, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 5, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Pine Level, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15821 | 21 CFR 111.60(a) | Production, in- process control system - design, quality |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15899 | 21 CFR 111.83(b)(1) | Reserve sample container-closure contamination,deterioration |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |