FDA Inspection 1180152 — Defender SD Manufacturing LLC
The FDA completed an inspection of Defender SD Manufacturing LLC on Sep 22, 2022 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 22, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |