FDA Inspection 1236331 — Applied Biologics LLC
The FDA completed an inspection of Applied Biologics LLC on April 18, 2024 in Scottsdale, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 18, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |