FDA Inspection
MTI Precision Products LLC.MTI Precision Products LLC. – FDA Inspection, Apr 30, 2014
Record Details
This FDA Inspection record concerns MTI Precision Products LLC., with an inspection on April 30, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MTI Precision Products LLC.
- Inspection Date
- April 30, 2014
- Product Type
- Devices
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ID · da178315-8dc3-4656-bc43-afb21287d3fd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 875249
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Showing 10 of 11 citations.
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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 |
| September 7, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 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 985380 - 2016-09-07
- FDA Inspection 901704 - 2014-11-06
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