FDA Inspection 749082 — Delasco, LLC
The FDA completed an inspection of Delasco, LLC on Oct 19, 2011 in Plano, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 19, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |