FDA Inspection 662425 — Specialized Medical Devices Inc
The FDA completed an inspection of Specialized Medical Devices Inc on May 7, 2010 in Huntsville, AL. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 7, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huntsville, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |