FDA Inspection
Adler MicroMed, Inc.Adler MicroMed, Inc. – FDA Inspection, Feb 12, 2026
Record Details
This FDA Inspection record concerns Adler MicroMed, Inc., with an inspection on February 12, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · 90c14c62-cf88-410a-aeb2-0497e466e637
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1302886
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate
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Other FDA inspections of Adler MicroMed, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2023 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| April 23, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 17, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Adler MicroMed, Inc.
- FDA Inspection 1218559 - 2023-08-24
- FDA Inspection 1089915 - 2019-04-23
- FDA Inspection 974410 - 2016-05-17
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