FDA Inspection 1000402 — Endo-Therapeutics, Inc.
The FDA completed an inspection of Endo-Therapeutics, Inc. on Feb 7, 2017 in Clearwater, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 7, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |