FDA Inspection 573593 — Pressure Tech, Inc.
The FDA completed an inspection of Pressure Tech, Inc. on Apr 2, 2009 in Freeport, NY. 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
- Apr 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Freeport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |