FDA Inspection 697903 — Merix Pharmaceutical Corporation
The FDA completed an inspection of Merix Pharmaceutical Corporation on Nov 22, 2010 in Barrington, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 22, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Barrington, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |