FDA Inspection
Helmer Inc.Helmer Inc. – FDA Inspection, Jul 31, 2017
Record Details
This FDA Inspection record concerns Helmer Inc., with an inspection on July 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fb5b16f5-6199-4c5b-abe1-5666bd716d4a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1020923
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Helmer Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2025 | Not classified | Detroit District Office | |
| June 4, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Helmer Inc.
- FDA Inspection 1273537 - 2025-06-09
- FDA Inspection 881562 - 2014-06-04
- FDA Inspection 735937 - 2011-07-21
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