FDA Inspection 1267125 — Nielsen Biosciences, Inc
The FDA completed an inspection of Nielsen Biosciences, Inc on Apr 17, 2025 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 17, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 9087 | 21 CFR 600.14(a)(1) | Who must report - receiving information |