FDA Inspection
Terry Yon & Associates, Inc. dba Tya PharmaceuticalsTerry Yon & Associates, Inc. dba Tya Pharmaceuticals – FDA Inspection, Nov 18, 2009
Record Details
This FDA Inspection record concerns Terry Yon & Associates, Inc. dba Tya Pharmaceuticals, with an inspection on November 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 18, 2009
- Product Type
- Drugs
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ID · 17d3ce9b-638e-4a26-88bb-777992b55670
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 629125
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.46(d)Penicillin air handling systems not kept separate
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.42(d)Penicillin processing area not kept separate
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Other FDA inspections of Terry Yon & Associates, Inc. dba Tya Pharmaceuticals
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Terry Yon & Associates, Inc. dba Tya Pharmaceuticals
- FDA Inspection 947535 - 2015-10-28
- FDA Inspection 840403 - 2013-07-10
- FDA Inspection 743548 - 2011-09-02
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