1229004
BLS Labs, LLC — FEI 3014573577
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12353 | 21 CFR 1271.190(d)(1) | Description of methods, schedule |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |