FDA Inspection
Schiller America, Inc.Schiller America, Inc. – FDA Inspection, Feb 19, 2019
Record Details
This FDA Inspection record concerns Schiller America, Inc., with an inspection on February 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ed1ec2b9-7f01-4412-b59b-02adf03b31ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079982
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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