FDA Inspection
Ella CS, SROElla CS, SRO – FDA Inspection, Mar 12, 2015
Record Details
This FDA Inspection record concerns Ella CS, SRO, with an inspection on March 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ella CS, SRO
- Inspection Date
- March 12, 2015
- Product Type
- Devices
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ID · ba2a12cc-0451-4c32-b011-2cd5a4ab447a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921071
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Ella CS, SRO
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ella CS, SRO
- FDA Inspection 1058595 - 2018-05-31
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