FDA Inspection 709731 — Defender SD Manufacturing LLC
The FDA completed an inspection of Defender SD Manufacturing LLC on February 2, 2011 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |