FDA Inspection
ARMM IncARMM Inc – FDA Inspection, Feb 12, 2018
Record Details
This FDA Inspection record concerns ARMM Inc, with an inspection on February 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3b086aa-79af-4bdf-b217-b8f8b11e3773
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041014
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of ARMM Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2024 | Not classified | Los Angeles District Office | |
| September 29, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 16, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ARMM Inc
- FDA Inspection 1241788 - 2024-05-23
- FDA Inspection 1132058 - 2020-09-29
- FDA Inspection 1087440 - 2019-04-16
- FDA Inspection 912585 - 2015-02-04
- FDA Inspection 659177 - 2010-04-23
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