FDA Inspection 851435 — Delta Pharma, Inc.
The FDA completed an inspection of Delta Pharma, Inc. on October 2, 2013 in Ripley, MS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 2, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ripley, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |