FDA Inspection
Hill Dermaceuticals, Inc.Hill Dermaceuticals, Inc. – FDA Inspection, Sep 10, 2010
Record Details
This FDA Inspection record concerns Hill Dermaceuticals, Inc., with an inspection on September 10, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hill Dermaceuticals, Inc.
- Inspection Date
- September 10, 2010
- Product Type
- Drugs
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ID · b81ebccb-bec5-4e2d-8d75-c41d109bc826
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680869
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(2)In-process sample representation/identification
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.198(a)Complaint Handling Procedure
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| August 10, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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