FDA Inspection
DreamLife, L.L.C.DreamLife, L.L.C. – FDA Inspection, Nov 15, 2010
Record Details
This FDA Inspection record concerns DreamLife, L.L.C., with an inspection on November 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- DreamLife, L.L.C.
- Inspection Date
- November 15, 2010
- Product Type
- Drugs
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ID · 909778bb-2aef-4e59-8b19-5c6a8c488fb4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 698591
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.80(d)Specifications - representative samples; unique lot
- 21 CFR 111.75(f)(2)Label - visual examination, review supplier"s documentation
- 21 CFR 111.16Written procedures - pest control
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.180(b)(2)Records - receiving; components, packaging, labels, products
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.75(e)Product - visually examine, identified
- 21 CFR 111.130Quality control operations - returned dietary supplement
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Other FDA inspections of DreamLife, L.L.C.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2011 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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