FDA Inspection 986279 — Formulation Technology LLC
The FDA completed an inspection of Formulation Technology LLC on August 23, 2016 in Oakdale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakdale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |