FDA Inspection
Zeus-MJB, Inc.Zeus-MJB, Inc. – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns Zeus-MJB, Inc., with an inspection on September 29, 2017, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · c80dff9d-0323-4b63-8381-a86ac5e14f22
Inspection Facts
- Inspection number
- 1027526
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.20(c)Management review dates
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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