FDA Inspection 673286 — Marlen Manufacturing & Development Co.
The FDA completed an inspection of Marlen Manufacturing & Development Co. on July 27, 2010 in Bedford, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bedford, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |