FDA Inspection
Ad-Tech Medical Instrument CorporationAd-Tech Medical Instrument Corporation – FDA Inspection, Jun 27, 2019
Record Details
This FDA Inspection record concerns Ad-Tech Medical Instrument Corporation, with an inspection on June 27, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 209e1bb5-6707-486a-99fe-1e53d5c6fc76
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095446
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.65Traceability Lack of or inadequate {see also 820.120(e)}
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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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 |
| 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 |
| November 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ad-Tech Medical Instrument Corporation
- FDA Inspection 1168052 - 2022-04-07
- FDA Inspection 1024308 - 2017-09-05
- FDA Inspection 884179 - 2014-06-20
- FDA Inspection 831497 - 2013-06-05
- FDA Inspection 808283 - 2012-11-26
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