FDA Inspection 594123 — Marlen Manufacturing & Development Co.
The FDA completed an inspection of Marlen Manufacturing & Development Co. on July 8, 2009 in Bedford, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bedford, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3162 | 21 CFR 820.184(b) | Quantity manufactured |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3267 | 21 CFR 820.86 | Maintained |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |