FDA Inspection 831076 — Simtra US LLC
The FDA completed an inspection of Simtra US LLC on May 10, 2013 in Bloomington, IN. 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
- May 10, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bloomington, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |