FDA Inspection 566296 — Missouri Vocational Enterprise
The FDA completed an inspection of Missouri Vocational Enterprise on Nov 23, 2008 in Bonne Terre, MO. 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 23, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bonne Terre, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |