FDA Inspection 1053895 — Apotek Produktion & Laboratorier AB
The FDA completed an inspection of Apotek Produktion & Laboratorier AB on June 1, 2018 in Kungens Kurva. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kungens Kurva (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |