Company
United StatesCircadiance LLC, Export, PA – FDA Inspections
Inspection records and compliance data for Circadiance LLC in Export, Pennsylvania. 6 FDA inspections on record, 2 Form 483s, last inspected August 30, 2024.
Company Profile
This profile covers Circadiance LLC based in Export, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 1, 2009. Last inspected August 30, 2024.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 30, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1235615 |
| March 20, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1098418 |
| April 7, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1010778 |
| January 30, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 816321 |
| February 16, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 709921 |
| April 1, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 572951 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Circadiance LLC
FEI Number
3006182632
Address
1010 Corporate Ln, Export, Pennsylvania 15632, United States
Country
United States
ID: 579e9940-5956-4465-8327-891022641742