FDA Inspection
Reckitt Benckiser, Inc.Reckitt Benckiser, Inc. – FDA Inspection, Feb 10, 2010
Record Details
This FDA Inspection record concerns Reckitt Benckiser, Inc., with an inspection on February 10, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Reckitt Benckiser, Inc.
- Inspection Date
- February 10, 2010
- Product Type
- Drugs
View Company Profile
ID · bf78c541-8b7d-439b-a288-631824e64400
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 646711
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 314.81(b)(1)(i)Mix-up
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| January 5, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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