FDA Inspection 856772 — Ascend Laboratories, LLC
The FDA completed an inspection of Ascend Laboratories, LLC on Dec 11, 2013 in Bedminster, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 11, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Bedminster, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |