FDA Inspection 883052 — Ricola Ag
The FDA completed an inspection of Ricola Ag on June 13, 2014 in Laufen. 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
- June 13, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Laufen (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |