FDA Inspection 1261862 — AVASOL LLC
The FDA completed an inspection of AVASOL LLC on February 12, 2025 in Santa Barbara, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Barbara, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4576 | 21 CFR 211.192 | No written record of investigation |