FDA Inspection
Terry Yon & Associates, Inc. dba Tya PharmaceuticalsTerry Yon & Associates, Inc. dba Tya Pharmaceuticals – FDA Inspection, Oct 28, 2015
Record Details
This FDA Inspection record concerns Terry Yon & Associates, Inc. dba Tya Pharmaceuticals, with an inspection on October 28, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 28, 2015
- Product Type
- Drugs
View Company Profile
ID · 47cfa2da-5d02-448d-8a97-652ca47ddd86
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 947535
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Terry Yon & Associates, Inc. dba Tya Pharmaceuticals
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| November 18, 2009 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Terry Yon & Associates, Inc. dba Tya Pharmaceuticals
- FDA Inspection 840403 - 2013-07-10
- FDA Inspection 743548 - 2011-09-02
- FDA Inspection 629125 - 2009-11-18
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.