FDA Inspection
MTI Precision Products LLC.MTI Precision Products LLC. – FDA Inspection, Nov 6, 2014
Record Details
This FDA Inspection record concerns MTI Precision Products LLC., with an inspection on November 6, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MTI Precision Products LLC.
- Inspection Date
- November 6, 2014
- Product Type
- Devices
View Company Profile
ID · 58ba5b41-112d-40fb-89a7-3bb5cd2992b4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 901704
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - 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 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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 |
| September 7, 2016 | 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 985380 - 2016-09-07
- FDA Inspection 875249 - 2014-04-30
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