FDA Inspection
Flexbar Machine CorpFlexbar Machine Corp – FDA Inspection, Apr 4, 2018
Record Details
This FDA Inspection record concerns Flexbar Machine Corp, with an inspection on April 4, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 72c4b31e-b686-46f7-874f-de929e12a4ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047534
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Flexbar Machine Corp
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2025 | NAI | New York District Office | Compliance: Medical Devices |
| July 22, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Flexbar Machine Corp
- FDA Inspection 1266364 - 2025-04-04
- FDA Inspection 888627 - 2014-07-22
- FDA Inspection 779265 - 2012-05-01
- FDA Inspection 625749 - 2009-10-30
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