FDA Inspection 1276411 — C.G. Laboratories, Inc.
The FDA completed an inspection of C.G. Laboratories, Inc. on July 24, 2025 in Granbury, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 24, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Granbury, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |