FDA Inspection 756483 — Melaleuca Inc
The FDA completed an inspection of Melaleuca Inc on Nov 2, 2011 in Idaho Falls, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 2, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Idaho Falls, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2618 | 21 CFR 211.198(b)(1) | Complaint Record required information |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |