FDA Inspection 1308318 — Advagen Holdings, Inc.
The FDA completed an inspection of Advagen Holdings, Inc. on May 13, 2026 in East Brunswick, NJ. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |