FDA Inspection 1223650 — AVASOL LLC
The FDA completed an inspection of AVASOL LLC on November 9, 2023 in Santa Barbara, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 9, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Barbara, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 21296 | 21 CFR 211.186(a) | Master production and control records, batch uniformity |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |