FDA Inspection
CMI Cosmetic Manufacturers Inc.CMI Cosmetic Manufacturers Inc. – FDA Inspection, Oct 24, 2012
Record Details
This FDA Inspection record concerns CMI Cosmetic Manufacturers Inc., with an inspection on October 24, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 24, 2012
- Product Type
- Drugs
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ID · dd26e592-0f15-4bc6-9725-3fdbf48fadc7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 805862
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.198(b)Maintenance of Complaint File
- 21 CFR 211.67(b)(4)Cleaning SOPs/equipment identification
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(b)SOPs not followed / documented
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