FDA Inspection 1281048 — Molecular Therapeutics LLC
The FDA completed an inspection of Molecular Therapeutics LLC on September 10, 2025 in Athens, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 10, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Athens, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |