FDA Inspection
Groman Inc.Groman Inc. – FDA Inspection, Jul 10, 2015
Record Details
This FDA Inspection record concerns Groman Inc., with an inspection on July 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Groman Inc.
- Inspection Date
- July 10, 2015
- Product Type
- Devices
View Company Profile
ID · 72c902c6-df43-44d8-bbb2-d61ae0033c41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933478
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Documentation of software validation
Full citation text and observation details available on the Dashboard.
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 |
| March 5, 2018 | NAI | 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 1043954 - 2018-03-05
- FDA Inspection 700357 - 2010-12-03
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