FDA Inspection 800736 — Millenium Natural Manufacturing
The FDA completed an inspection of Millenium Natural Manufacturing on September 21, 2012 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15868 | 21 CFR 111.75(b)(2) | Specifications met - deviation, unanticipated occurrence |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |
| 15976 | 21 CFR 111.123 | Quality control operations - master, batch, manufacturing |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |