FDA Inspection 568063 — Folsom Metal Products, Inc.
The FDA completed an inspection of Folsom Metal Products, Inc. on Feb 23, 2009 in Pelham, AL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 23, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pelham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3377 | 21 CFR 820.198(e)(3) | Device identification and control number |
| 3700 | 21 CFR 820.250(a) | Invalid technique |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |