FDA Inspection
Micro Current Technology, Inc.Micro Current Technology, Inc. – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns Micro Current Technology, Inc., with an inspection on January 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 91d74f64-20c2-4e4c-9edb-ebdfb5110e5c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1037390
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Micro Current Technology, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 6, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Micro Current Technology, Inc.
- FDA Inspection 1077449 - 2019-01-28
- FDA Inspection 779254 - 2012-04-06
- FDA Inspection 755695 - 2011-12-02
- FDA Inspection 604554 - 2009-07-22
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