FDA Inspection
Circadiance LLCCircadiance LLC – FDA Inspection, Aug 30, 2024
Record Details
This FDA Inspection record concerns Circadiance LLC, with an inspection on August 30, 2024, issued by the Philadelphia District Office, covering medical devices & rad health.
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ID · dc9197b9-11a7-42ea-807d-1badad8b4330
Inspection Facts
- Inspection number
- 1235615
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Circadiance LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 16, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Circadiance LLC
- FDA Inspection 1098418 - 2019-03-20
- FDA Inspection 1010778 - 2017-04-07
- FDA Inspection 816321 - 2013-01-30
- FDA Inspection 709921 - 2011-02-16
- FDA Inspection 572951 - 2009-04-01
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