FDA Inspection
Sonar Products, Inc.Sonar Products, Inc. – FDA Inspection, Nov 12, 2014
Record Details
This FDA Inspection record concerns Sonar Products, Inc., with an inspection on November 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sonar Products, Inc.
- Inspection Date
- November 12, 2014
- Product Type
- Drugs
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ID · d68646dd-3ece-4242-932a-6f1be319055b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 899650
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
12- 21 CFR 820.198(a)Complaints
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 211.100(a)Absence of Written Procedures
Showing 10 of 12 citations.
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Other FDA inspections of Sonar Products, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 922999 - 2015-04-02
- 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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