FDA Inspection 947620 — Acella Pharmaceuticals, LLC
The FDA completed an inspection of Acella Pharmaceuticals, LLC on October 28, 2015 in Alpharetta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 28, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |