Apotek Produktion & Laboratorier AB — FDA Facility Profile
Apotek Produktion & Laboratorier AB is an FDA-registered facility (FEI 3004967053) located in SE-141 75, SE. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 28, 2022: No Action Indicated (NAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 28, 2022 | No Action Indicated (NAI) | No citations listed |
| Jun 1, 2018 | Voluntary Action Indicated (VAI) | Cleaning SOP/inspection (21 CFR 211.67(b)(6)) Computer control of master formula records (21 CFR 211.68(b)) Failing drug products not rejected (21 CFR 211.165(f)) Investigations of discrepancies, failures (21 CFR 211.192) and 1 more |
| Oct 13, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 13, 2014 | Voluntary Action Indicated (VAI) | Annual visual exams of drug products (21 CFR 211.170(b)) |
| Dec 15, 2011 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Apotek Produktion & Laboratorier AB
- Location
- SE-141 75 (SE)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; MANUFACTURE
- Source
- decrs