FDA Inspection 562922 — Buffalo Filter, LLC
The FDA completed an inspection of Buffalo Filter, LLC on Nov 7, 2008 in Lancaster, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 7, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lancaster, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3300 | 21 CFR 820.100(a)(1) | Statistical methodology |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |