FDA Inspection 1101986 — Aurena Laboratories AB
The FDA completed an inspection of Aurena Laboratories AB on September 13, 2019 in Karlstad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Karlstad (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |