FDA Inspection
Reckitt Benckiser, Inc.Reckitt Benckiser, Inc. – FDA Inspection, Jan 5, 2011
Record Details
This FDA Inspection record concerns Reckitt Benckiser, Inc., with an inspection on January 5, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Reckitt Benckiser, Inc.
- Inspection Date
- January 5, 2011
- Product Type
- Drugs
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ID · 1e926039-47f9-438b-940d-9ee53519c4b6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 701774
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
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Other FDA inspections of Reckitt Benckiser, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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