FDA Inspection
K2M, Inc.K2M, Inc. – FDA Inspection, Nov 16, 2016
Record Details
This FDA Inspection record concerns K2M, Inc., with an inspection on November 16, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c4c5ce42-ecd4-418c-8dc7-0f046a30700b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 992904
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of K2M, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 21, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 27, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 12, 2017 | Not classified | Baltimore District Office |
Other documents for K2M, Inc.
- FDA Inspection 1236122 - 2024-03-21
- FDA Inspection 1168720 - 2022-04-21
- FDA Inspection 1148726 - 2021-07-27
- FDA Inspection 1076835 - 2018-12-07
- FDA Inspection 1078529 - 2017-10-12
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