FDA Inspection 629125 — Terry Yon & Associates, Inc. dba Tya Pharmaceuticals
The FDA completed an inspection of Terry Yon & Associates, Inc. dba Tya Pharmaceuticals on November 18, 2009 in Tallahassee, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 18, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tallahassee, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3551 | 21 CFR 211.46(d) | Penicillin air handling systems not kept separate |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |