FDA Inspection
MTI Precision Products LLC.MTI Precision Products LLC. – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns MTI Precision Products LLC., with an inspection on March 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b1210355-9eac-4d20-bf9d-933ed334df38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005671
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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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 |
| September 7, 2016 | OAI | 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 985380 - 2016-09-07
- FDA Inspection 901704 - 2014-11-06
- FDA Inspection 875249 - 2014-04-30
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