FDA Inspection
MTI Precision Products LLC.MTI Precision Products LLC. – FDA Inspection, Sep 7, 2016
Record Details
This FDA Inspection record concerns MTI Precision Products LLC., with an inspection on September 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MTI Precision Products LLC.
- Inspection Date
- September 7, 2016
- Product Type
- Devices
View Company Profile
ID · 94ac8cbb-2e36-4b96-bc14-b9c69192c5ab
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 985380
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MTI Precision Products LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 30, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MTI Precision Products LLC.
- FDA Inspection 1201688 - 2023-03-10
- FDA Inspection 1005671 - 2017-03-16
- FDA Inspection 901704 - 2014-11-06
- FDA Inspection 875249 - 2014-04-30
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.