FDA Inspection 1101451 — Alimera Sciences Inc
The FDA completed an inspection of Alimera Sciences Inc on September 9, 2019 in Baudette, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 9, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Baudette, MN (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6731 | 21 CFR 314.80(c) | [NDA prod] Fail to submit report in apprvd electronic format |