FDA Inspection 1147426 — Re-Gen Active Lab Inc
The FDA completed an inspection of Re-Gen Active Lab Inc on Jul 28, 2021 in Irving, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 11 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 28, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 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 |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |