FDA Inspection
CMS Imaging, Inc.CMS Imaging, Inc. – FDA Inspection, Jun 18, 2010
Record Details
This FDA Inspection record concerns CMS Imaging, Inc., with an inspection on June 18, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CMS Imaging, Inc.
- Inspection Date
- June 18, 2010
- Product Type
- Drugs
View Company Profile
ID · 2b223ac9-c5de-4f6d-bd1a-a27568aec3cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 667617
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.150(b)Distribution Recall System
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