FDA Inspection
Ad-Tech Medical Instrument CorporationAd-Tech Medical Instrument Corporation – FDA Inspection, Feb 24, 2011
Record Details
This FDA Inspection record concerns Ad-Tech Medical Instrument Corporation, with an inspection on February 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 24, 2011
- Product Type
- Devices
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ID · 5b4e5755-f2ab-448e-a072-d3990e7ace5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710968
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 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 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Ad-Tech Medical Instrument Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 5, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 20, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 5, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ad-Tech Medical Instrument Corporation
- FDA Inspection 1168052 - 2022-04-07
- FDA Inspection 1095446 - 2019-06-27
- FDA Inspection 1024308 - 2017-09-05
- FDA Inspection 884179 - 2014-06-20
- FDA Inspection 831497 - 2013-06-05
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