FDA Inspection 995279 — VistaPharm LLC
The FDA completed an inspection of VistaPharm LLC on Dec 13, 2016 in Largo, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |