FDA Inspection
Eastern Cranial Affiliates, LLCEastern Cranial Affiliates, LLC – FDA Inspection, Apr 13, 2011
Record Details
This FDA Inspection record concerns Eastern Cranial Affiliates, LLC, with an inspection on April 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 13, 2011
- Product Type
- Devices
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ID · f6f9341f-6e0c-4e32-8d98-3d00014ec554
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 719457
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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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 |
| February 2, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2011 | NAI | 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 1039722 - 2018-02-02
- FDA Inspection 749386 - 2011-10-12
- FDA Inspection 667087 - 2010-06-18
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