FDA Inspection
Marlen Manufacturing & Development Co.Marlen Manufacturing & Development Co. – FDA Inspection, May 6, 2026
Record Details
This FDA Inspection record concerns Marlen Manufacturing & Development Co., with an inspection on May 6, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
- Inspection Date
- May 6, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 55b2b505-df68-4029-9827-902ce84c7baf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1315724
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Marlen Manufacturing & Development Co.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 8, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Marlen Manufacturing & Development Co.
- FDA Inspection 1171414 - 2022-06-08
- FDA Inspection 1004059 - 2017-03-13
- FDA Inspection 673286 - 2010-07-27
- FDA Inspection 594123 - 2009-07-08
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