FDA Inspection 1237556 — North American Science Associates, LLC
The FDA completed an inspection of North American Science Associates, LLC on May 2, 2024 in Marietta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12377 | 21 CFR 1271.210(c) | In-house reagent production |
| 12406 | 21 CFR 1271.250(a) | Design of labeling procedures |