FDA Inspection
ASI Medical, Inc.ASI Medical, Inc. – FDA Inspection, Nov 29, 2010
Record Details
This FDA Inspection record concerns ASI Medical, Inc., with an inspection on November 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ASI Medical, Inc.
- Inspection Date
- November 29, 2010
- Product Type
- Devices
View Company Profile
ID · 22b11768-235a-4dee-9244-b049934c38dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 699980
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 16 citations.
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Other FDA inspections of ASI Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2018 | Not classified | Denver District Office | |
| December 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ASI Medical, Inc.
- FDA Inspection 1081697 - 2018-02-02
- FDA Inspection 907171 - 2014-12-17
- FDA Inspection 760079 - 2011-12-22
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