FDA Inspection 706469 — Edlaw Pharmaceutical, Inc.
The FDA completed an inspection of Edlaw Pharmaceutical, Inc. on January 10, 2011 in Farmingdale, NY. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |