FDA Inspection 564281 — MLM Inc
The FDA completed an inspection of MLM Inc on Feb 23, 2009 in Salem, IL. 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
- Feb 23, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salem, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |