FDA Inspection 1171414 — Marlen Manufacturing & Development Co.
The FDA completed an inspection of Marlen Manufacturing & Development Co. on June 8, 2022 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
- June 8, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bedford, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |