FDA Inspection 1010067 — AstraZeneca AB
The FDA completed an inspection of AstraZeneca AB on February 7, 2017 in Sodertalje. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sodertalje (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 3598 | 21 CFR 211.132(b)(1) | OTC products requiring tamper-evident packaging |