FDA Inspection
Groman Inc.Groman Inc. – FDA Inspection, Mar 5, 2018
Record Details
This FDA Inspection record concerns Groman Inc., with an inspection on March 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a4b08735-c542-4724-b470-29cbafbff8f5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1043954
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Groman Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2026 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 10, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 3, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Groman Inc.
- FDA Inspection 1308980 - 2026-03-17
- FDA Inspection 1206335 - 2023-03-07
- FDA Inspection 933478 - 2015-07-10
- FDA Inspection 700357 - 2010-12-03
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