FDA Inspection 698591 — DreamLife, L.L.C.
The FDA completed an inspection of DreamLife, L.L.C. on November 15, 2010 in Covington, LA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 15, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Covington, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15878 | 21 CFR 111.75(e) | Product - visually examine, identified |
| 15880 | 21 CFR 111.75(f)(2) | Label - visual examination, review supplier's documentation |
| 15894 | 21 CFR 111.80(d) | Specifications - representative samples; unique lot |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16000 | 21 CFR 111.130 | Quality control operations - returned dietary supplement |