FDA Inspection 575250 — Compass Richmar LLC
The FDA completed an inspection of Compass Richmar LLC on April 9, 2009 in Chattanooga, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chattanooga, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |