FDA Inspection 729855 — DreamLife, L.L.C.
The FDA completed an inspection of DreamLife, L.L.C. on June 8, 2011 in Covington, LA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 8, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Covington, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15880 | 21 CFR 111.75(f)(2) | Label - visual examination, review supplier's documentation |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |