FDA Inspection
Sonar Products, Inc.Sonar Products, Inc. – FDA Inspection, Mar 18, 2014
Record Details
This FDA Inspection record concerns Sonar Products, Inc., with an inspection on March 18, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sonar Products, Inc.
- Inspection Date
- March 18, 2014
- Product Type
- Drugs
View Company Profile
ID · adc2a59c-1def-42b2-9ee0-32450ca7bd50
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 871333
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
4- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
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 |
| November 12, 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 899650 - 2014-11-12
- FDA Inspection 818381 - 2013-02-15
- FDA Inspection 762450 - 2012-01-09
- FDA Inspection 667709 - 2010-06-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.