FDA Inspection 1081909 — Stemell Inc
The FDA completed an inspection of Stemell Inc on March 8, 2019 in San Juan Capistrano, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 8, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Juan Capistrano, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 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 |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |