FDA Inspection
Sonar Products, Inc.Sonar Products, Inc. – FDA Inspection, Apr 2, 2015
Record Details
This FDA Inspection record concerns Sonar Products, Inc., with an inspection on April 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sonar Products, Inc.
- Inspection Date
- April 2, 2015
- Product Type
- Drugs
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ID · ca6a7ce3-2f1a-4147-8321-17164b71a3d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 922999
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.68(b)input/output verification
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Other FDA inspections of Sonar Products, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 18, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 15, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 9, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sonar Products, Inc.
- FDA Inspection 899650 - 2014-11-12
- FDA Inspection 871333 - 2014-03-18
- FDA Inspection 818381 - 2013-02-15
- FDA Inspection 762450 - 2012-01-09
- FDA Inspection 667709 - 2010-06-21
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