FDA Inspection 675492 — Formulation Technology LLC
The FDA completed an inspection of Formulation Technology LLC on August 13, 2010 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 13, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakdale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |