FDA Inspection 557976 — Windstone Medical Packaging, Inc.
The FDA completed an inspection of Windstone Medical Packaging, Inc. on Jan 16, 2009 in Apopka, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 16, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Apopka, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |