FDA Inspection 1315724 — Marlen Manufacturing & Development Co.
The FDA completed an inspection of Marlen Manufacturing & Development Co. on May 6, 2026 in Bedford, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bedford, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |