FDA Inspection 743272 — C.G. Laboratories, Inc.
The FDA completed an inspection of C.G. Laboratories, Inc. on September 7, 2011 in Granbury, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Granbury, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |