FDA Inspection 848618 — Millenia Productions LLC
The FDA completed an inspection of Millenia Productions LLC on Nov 6, 2013 in Wichita, KS. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 6, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Wichita, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |