FDA Inspection 1314924 — GVS TM, Inc
The FDA completed an inspection of GVS TM, Inc on May 1, 2026 in Covina, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 14 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 1, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Covina, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4411 | 21 CFR 211.194(a)(6) | Test results, comparison with standards not included |