FDA Inspection 696481 — Melaleuca Inc
The FDA completed an inspection of Melaleuca Inc on Nov 3, 2010 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 3, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Idaho Falls, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1419 | 21 CFR 211.42(c)(8) | Released Drug Products Area |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |