FDA Inspection 819106 — Avella of Deer Valley dba Avella Specialty Pharmacy
The FDA completed an inspection of Avella of Deer Valley dba Avella Specialty Pharmacy on February 25, 2013 in Phoenix, AZ. 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
- February 25, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4576 | 21 CFR 211.192 | No written record of investigation |