FDA Inspection
Titan Implants, IncTitan Implants, Inc – FDA Inspection, Mar 16, 2023
Record Details
This FDA Inspection record concerns Titan Implants, Inc, with an inspection on March 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Melissa A. Zuppe
- Monica L. Gutierrez (Issuing Officer)
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ID · ae59b7a2-a613-4bda-a238-53d7f2d9bcff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199996
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
19- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.184DHR content
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Other FDA inspections of Titan Implants, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2025 | NAI | New Jersey District Office | Postmarket Assurance: Medical Devices |
| January 16, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 6, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 17, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Titan Implants, Inc
- FDA Inspection 1261614 - 2025-02-20
- FDA Inspection 1037675 - 2018-01-16
- FDA Inspection 870134 - 2014-03-17
- FDA Inspection 733500 - 2011-07-06
- FDA Inspection 563269 - 2009-02-17
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