FDA Inspection 840156 — Formulation Technology LLC
The FDA completed an inspection of Formulation Technology LLC on Jul 18, 2013 in Oakdale, CA. 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
- Jul 18, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakdale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |