FDA Inspection
Ad-Tech Medical Instrument CorporationAd-Tech Medical Instrument Corporation – FDA Inspection, Jun 5, 2013
Record Details
This FDA Inspection record concerns Ad-Tech Medical Instrument Corporation, with an inspection on June 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 5, 2013
- Product Type
- Devices
View Company Profile
ID · d5b8a0cf-8416-445a-bd5f-d046f3069d01
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 831497
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(h)Incorrect translation to production specifications
Full citation text and observation details available on the Dashboard.
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 |
| 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 1095446 - 2019-06-27
- FDA Inspection 1024308 - 2017-09-05
- FDA Inspection 884179 - 2014-06-20
- FDA Inspection 808283 - 2012-11-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.