FDA Inspection 788106 — VistaPharm LLC
The FDA completed an inspection of VistaPharm LLC on June 15, 2012 in Largo, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |