FDA Inspection
Eastern Cranial Affiliates, LLCEastern Cranial Affiliates, LLC – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Eastern Cranial Affiliates, LLC, with an inspection on February 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8ccd5dce-48c2-4caa-b240-a6a2de2c2918
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039722
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Eastern Cranial Affiliates, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 18, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Eastern Cranial Affiliates, LLC
- FDA Inspection 1242962 - 2024-06-13
- FDA Inspection 749386 - 2011-10-12
- FDA Inspection 719457 - 2011-04-13
- FDA Inspection 667087 - 2010-06-18
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