FDA Inspection 781924 — Celltex Therapeutics Corporation
The FDA completed an inspection of Celltex Therapeutics Corporation on April 27, 2012 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 27, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 12475 | 21 CFR 1271.370(a) | Clear and accurate label |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1794 | 21 CFR 211.80(d) | Disposition recorded by lot identification |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3558 | 21 CFR 211.52 | Washing and toilet facilities not provided and accessible |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4576 | 21 CFR 211.192 | No written record of investigation |